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Spanish Manufacturer · Patient-Specific 3D Planning, Guides and Implants

Tailor Surgery

Spanish manufacturer of patient-specific 3D surgical plans, cutting and drill guides and custom-made implants, built from the patient's own CT and ordered one case at a time. Spin-off of the 3D Surgical Planning Laboratory at Hospital Universitari Parc Taulí, Sabadell. In Cyprus through OrganoGEN, with the GESY reimbursement application prepared and submitted per case.

Sabadell, Spain · tailorsurgery.com · Cyprus: Authorized distributor in Cyprus

SabadellSpain
(Barcelona province)
20143D planning laboratory
at Parc Taulí
1,000+Orthopaedic surgeries
behind the laboratory
48 hCT upload to
costed proposal
sciencePatient-SpecificpublicEU MDR Annex XIIIverifiedISO 13485 Manufacturersupport_agentOrganoGEN Case Support

In One Paragraph

Tailor Surgery, S.L. is a Spanish manufacturer of patient-specific surgical solutions: a 3D surgical plan built from the patient's own CT, cutting and drill guides that seat on the bone in one position only, and custom-made implants for the anatomy no stock implant fits. Founded as a spin-off of the 3D Surgical Planning Laboratory established in 2014 at Hospital Universitari Parc Taulí, Sabadell, with more than 1,000 orthopaedic surgeries behind the laboratory according to the manufacturer. Devices are custom-made under EU MDR 2017/745, Annex XIII, and the manufacturer is ISO 13485 certified. OrganoGEN is the authorized distributor in Cyprus and runs each case end to end, including the individual GESY reimbursement application submitted before manufacture.

Overview

Tailor Surgery, S.L. is based in Sabadell, in the province of Barcelona. It is a spin-off of the 3D Surgical Planning Laboratory established in 2014 at Hospital Universitari Parc Taulí, one of the reference units in Europe for 3D surgical planning, and it was founded to bring that laboratory's method out of a single hospital and into routine practice elsewhere.

The team pairs surgeons with biomedical engineers, subspecialty by subspecialty, rather than treating planning as a purely technical service. The founder and Chief Medical Officer is Dr. Ferran Fillat-Gomà, a shoulder and elbow surgeon who publishes on 3D planning in upper-extremity surgery. According to the manufacturer, more than 1,000 surgeries have now been performed across some 30 hospitals using its plans, guides and implants.

The company holds ISO 13485 certification for the manufacture of medical devices, issued by NQA in October 2025, and its website carries Web Médica Acreditada accreditation. It took first prize at the ESADE Entrepreneurship Summit in 2024.

Technology focus

For the deformity that no off-the-shelf implant fits and no freehand osteotomy reliably corrects.

A malunion planned from plain films becomes a judgment call once the saw is in your hand, and the correction you get is the correction you can see. Tailor Surgery builds a digital twin from the CT, quantifies the deformity in three planes, and turns the plan into a guide that sits on the bone in one position only. Reported planning-to-execution deviation is under 3° and 2 mm, a manufacturer summary of its cited studies, several of which evaluate patient-specific instrumentation in general rather than Tailor Surgery devices specifically.

The offer is structured as three levels rather than a catalogue of parts. CORE is the diagnostic study from the medical images plus the treatment proposal and the 3D digital plan, validated by the manufacturer's own surgeons. ADVANCED adds the digital step-by-step surgical technique, the patient-specific guides, and the essential standard instrumentation for that procedure. EXCELLENCE adds the custom-made implant. The manufacturer's website describes the same three levels as 3D planning, 3D planning with custom-made guides, and 3D planning with custom-made guides and implants.

Everything for the case arrives in one single-use box: the guides, any custom implant, the specific screw sets, the single-use instrumentation, a surgeon folder with the surgical technique and a during-surgery summary, and a separate scrub-nurse folder with the instructions for use.

Products distributed in Cyprus

Regulatory & manufacturing

Device categoryCustom-made devices under EU MDR 2017/745, Annex XIII. Custom-made devices do not carry a CE mark by definition
Manufacturing licenceSpanish custom-made device manufacturing authorization FMP005CAT, issued pursuant to Royal Decree 192/2023 and Royal Decree 437/2002
Quality systemISO 13485 certified (NQA, October 2025)
ManufacturingSabadell, Spain
Website accreditationWeb Médica Acreditada
Distribution in CyprusOrganoGEN Limited, distributor under EU MDR 2017/745 Article 14

Clinical evidence

Fillat-Gomà et al. 2021

Work from the Parc Taulí laboratory the company grew out of, on 3D planning in upper-extremity surgery.

PubMed 33632605
Marcano-Fernández et al. 2021

Custom 3D-printed guide against freehand fixation. The manufacturer cites up to 43% improvement in surgical time from this study.

PubMed 34647500
Manufacturer clinical case reports 2026

Nine documented cases across distal radius and forearm malunion, glenoid defect, tibial osteotomy, acetabular revision and limb reconstruction.

Single manufacturer-reported cases, not a series

GESY in Cyprus

Tailor Surgery devices have no standard GESY code, because each one is made for a single patient. Each case goes through an individual reimbursement application, which OrganoGEN prepares and submits once the surgeon has approved the proposed plan. Approval is secured before manufacturing begins, because a custom-made device cannot be cancelled once production starts.

For self-pay and international patients, the complete system is quoted up front at a fixed price for the case. Surgeons can send a case to start, and the costed proposal comes back within 48 hours.

Partnership with OrganoGEN

OrganoGEN is the authorized distributor of Tailor Surgery in Cyprus, acting as distributor under EU MDR 2017/745 Article 14, under an exclusive Cyprus collaboration agreement. Nothing here is held in stock: every case is a bespoke order that begins with a CT and ends with a single-use box in the operating theatre.

OrganoGEN runs the case end to end. We take the CT to the manufacturer, return the costed and clinically validated proposal to the surgeon, prepare and submit the individual GESY application before anything is manufactured, and cover the case in theatre. Cypriot cases are already running through this pathway. Where the plan calls for graft or fixation alongside the custom parts, SmartBone® and Hofer Osteosynthesis are available from OrganoGEN as well.

Related procedures

Frequently asked questions

Where is Tailor Surgery based?
Sabadell, in the province of Barcelona, Spain. The company is a spin-off of the 3D Surgical Planning Laboratory established in 2014 at Hospital Universitari Parc Taulí.
Are Tailor Surgery devices CE-marked?
No, and they are not meant to be. These are custom-made devices under Annex XIII of EU MDR 2017/745, made for one named patient on a prescription. Custom-made devices are placed on the market under a statement rather than a CE mark. Tailor Surgery manufactures under Spanish custom-made device authorization FMP005CAT and holds ISO 13485 certification for its quality system.
What does patient-specific actually mean here?
The plan, the guides and, at the EXCELLENCE level, the implant are all built from that patient's own CT. A guide is designed to seat on their bone surface in one position only, so the cut or the drill trajectory that was planned on screen is the one executed in theatre.
How long does a case take?
The clinically validated proposal comes back within 48 hours of the CT reaching the platform. After the surgeon approves it and reimbursement is secured, manufacture and delivery in a single-use box take 5 to 10 working days, depending on case complexity.
Is it covered by GESY?
There is no standard GESY code for a device made for one patient. OrganoGEN prepares and submits an individual reimbursement application per case and secures approval before manufacturing begins, because a custom-made device cannot be cancelled once it starts.
Which procedures does Tailor Surgery support?
The manufacturer lists validated procedures across hand and wrist, shoulder and elbow, hip, knee, foot and ankle, spine, and bone reconstruction with allograft or custom-made prostheses. Common cases in Cyprus are malunion correction, deformity correction around the knee, and revision arthroplasty with bone loss.
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Tailor Surgery
Spanish Manufacturer · Patient-Specific 3D Planning, Guides and Implants

Tailor Surgery

Spanish manufacturer of patient-specific 3D surgical plans, cutting and drill guides and custom-made implants, built from the patient's own CT and ordered one case at a time. Spin-off of the 3D Surgical Planning Laboratory at Hospital Universitari Parc Taulí, Sabadell. In Cyprus through OrganoGEN, with the GESY reimbursement application prepared and submitted per case.

sciencePatient-SpecificpublicEU MDR Annex XIIIverifiedISO 13485 Manufacturersupport_agentOrganoGEN Case Support

In One Paragraph

Tailor Surgery, S.L. is a Spanish manufacturer of patient-specific surgical solutions: a 3D surgical plan built from the patient's own CT, cutting and drill guides that seat on the bone in one position only, and custom-made implants for the anatomy no stock implant fits. Founded as a spin-off of the 3D Surgical Planning Laboratory established in 2014 at Hospital Universitari Parc Taulí, Sabadell, with more than 1,000 orthopaedic surgeries behind the laboratory according to the manufacturer. Devices are custom-made under EU MDR 2017/745, Annex XIII, and the manufacturer is ISO 13485 certified. OrganoGEN is the authorized distributor in Cyprus and runs each case end to end, including the individual GESY reimbursement application submitted before manufacture.

Overview

Overview

Tailor Surgery, S.L. is based in Sabadell, in the province of Barcelona. It is a spin-off of the 3D Surgical Planning Laboratory established in 2014 at Hospital Universitari Parc Taulí, one of the reference units in Europe for 3D surgical planning, and it was founded to bring that laboratory's method out of a single hospital and into routine practice elsewhere.

The team pairs surgeons with biomedical engineers, subspecialty by subspecialty, rather than treating planning as a purely technical service. The founder and Chief Medical Officer is Dr. Ferran Fillat-Gomà, a shoulder and elbow surgeon who publishes on 3D planning in upper-extremity surgery. According to the manufacturer, more than 1,000 surgeries have now been performed across some 30 hospitals using its plans, guides and implants.

Technology

Technology focus

For the deformity that no off-the-shelf implant fits and no freehand osteotomy reliably corrects.

A malunion planned from plain films becomes a judgment call once the saw is in your hand, and the correction you get is the correction you can see. Tailor Surgery builds a digital twin from the CT, quantifies the deformity in three planes, and turns the plan into a guide that sits on the bone in one position only. Reported planning-to-execution deviation is under 3° and 2 mm, a manufacturer summary of its cited studies, several of which evaluate patient-specific instrumentation in general rather than Tailor Surgery devices specifically.

Distributed

Products distributed in Cyprus

Regulatory

Regulatory & manufacturing

Device category
Custom-made devices under EU MDR 2017/745, Annex XIII. Custom-made devices do not carry a CE mark by definition
Manufacturing licence
Spanish custom-made device manufacturing authorization FMP005CAT, issued pursuant to Royal Decree 192/2023 and Royal Decree 437/2002
Quality system
ISO 13485 certified (NQA, October 2025)
Manufacturing
Sabadell, Spain
Website accreditation
Web Médica Acreditada
Distribution in Cyprus
OrganoGEN Limited, distributor under EU MDR 2017/745 Article 14
Evidence

Clinical evidence

Fillat-Gomà et al. 2021 Work from the Parc Taulí laboratory the company grew out of, on 3D planning in upper-extremity surgery. PubMed 33632605
Marcano-Fernández et al. 2021 Custom 3D-printed guide against freehand fixation. The manufacturer cites up to 43% improvement in surgical time from this study. PubMed 34647500
Manufacturer clinical case reports 2026 Nine documented cases across distal radius and forearm malunion, glenoid defect, tibial osteotomy, acetabular revision and limb reconstruction. Single manufacturer-reported cases, not a series
GESY

GESY in Cyprus

Tailor Surgery devices have no standard GESY code, because each one is made for a single patient. Each case goes through an individual reimbursement application, which OrganoGEN prepares and submits once the surgeon has approved the proposed plan. Approval is secured before manufacturing begins, because a custom-made device cannot be cancelled once production starts.

For self-pay and international patients, the complete system is quoted up front at a fixed price for the case. Surgeons can send a case to start, and the costed proposal comes back within 48 hours.

OrganoGEN

Partnership with OrganoGEN

OrganoGEN is the authorized distributor of Tailor Surgery in Cyprus, acting as distributor under EU MDR 2017/745 Article 14, under an exclusive Cyprus collaboration agreement. Nothing here is held in stock: every case is a bespoke order that begins with a CT and ends with a single-use box in the operating theatre.

OrganoGEN runs the case end to end. We take the CT to the manufacturer, return the costed and clinically validated proposal to the surgeon, prepare and submit the individual GESY application before anything is manufactured, and cover the case in theatre. Cypriot cases are already running through this pathway. Where the plan calls for graft or fixation alongside the custom parts, SmartBone® and Hofer Osteosynthesis are available from OrganoGEN as well.

FAQ

Frequently asked questions

Where is Tailor Surgery based?
Sabadell, in the province of Barcelona, Spain. The company is a spin-off of the 3D Surgical Planning Laboratory established in 2014 at Hospital Universitari Parc Taulí.
Are Tailor Surgery devices CE-marked?
No, and they are not meant to be. These are custom-made devices under Annex XIII of EU MDR 2017/745, made for one named patient on a prescription. Custom-made devices are placed on the market under a statement rather than a CE mark. Tailor Surgery manufactures under Spanish custom-made device authorization FMP005CAT and holds ISO 13485 certification for its quality system.
What does patient-specific actually mean here?
The plan, the guides and, at the EXCELLENCE level, the implant are all built from that patient's own CT. A guide is designed to seat on their bone surface in one position only, so the cut or the drill trajectory that was planned on screen is the one executed in theatre.
How long does a case take?
The clinically validated proposal comes back within 48 hours of the CT reaching the platform. After the surgeon approves it and reimbursement is secured, manufacture and delivery in a single-use box take 5 to 10 working days, depending on case complexity.
Is it covered by GESY?
There is no standard GESY code for a device made for one patient. OrganoGEN prepares and submits an individual reimbursement application per case and secures approval before manufacturing begins, because a custom-made device cannot be cancelled once it starts.
Which procedures does Tailor Surgery support?
The manufacturer lists validated procedures across hand and wrist, shoulder and elbow, hip, knee, foot and ankle, spine, and bone reconstruction with allograft or custom-made prostheses. Common cases in Cyprus are malunion correction, deformity correction around the knee, and revision arthroplasty with bone loss.