Overview
KeriFlex® is a family of flexible, one-piece, hinged silicone-elastomer implants used for cementless replacement of the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) finger joints. The construct restores pain-free range of motion in fingers affected by rheumatoid, degenerative or post-traumatic arthritis where conservative care has failed.
KeriMedical, the Swiss manufacturer, supplies KeriFlex® in 13 sizes: 7 MCP (sizes 00 to 60) and 6 PIP (sizes 0 to 5). Each implant is a single-piece silicone elastomer hinge with the proximal and distal stems set at an angle that mimics the natural posture of the hand at rest: 30° at the MCP joint and 15° at the PIP joint. The geometry respects the anatomic centre of rotation, limits conflict with the extensor mechanism, and tolerates the natural compressive stress of the joint.
Bench testing validates KeriFlex® to 10 million flex cycles across a 0° to 90° flexion-extension range. The implants are single-use, non-absorbable, and supplied sterile. The dedicated ancillary set uses progressive proximal and distal rasps, a bone awl, a starter and a conical drill, and is validated for steam sterilisation at 134°C / 18 min and 134°C / 3 min per ANSI/AAMI ST79 and EN ISO 17665.
KeriFlex® is CE-marked under EU MDR 2017/745 (notified body 1250) and FDA 510(k) cleared in the United States as the *KeriFlex® MCP and PIP Finger Joint Prostheses* (K211385, decision date 27 July 2022). It sits within the silicone MCP and PIP arthroplasty class, which has the most mature long-term evidence base of any finger-joint replacement technology.
OrganoGEN is the Cyprus distributor and provides surgical support at every implantation. KeriFlex® is GESY-covered when implanted by a participating hand surgeon at a GESY-contracted hospital.
Indications & Contraindications
Indicated For
- Rheumatoid arthritis of the MCP or PIP joints with painful deformity
- Primary (degenerative) osteoarthritis of the MCP or PIP joints
- Post-traumatic finger-joint arthritis
- Failed conservative management with persistent pain, stiffness or fixed deformity
Contraindicated For
- Active local or systemic infection
- Bone quality judged inadequate by the surgeon
- Severely compromised soft-tissue envelope (skin, extensor mechanism, collateral ligaments)
- Skeletal immaturity (children, adolescents)
- Pregnancy or breast-feeding
Technical Specifications
| Manufacturer | KeriMedical SA, Geneva, Switzerland |
|---|---|
| Material | Silicone elastomer (one-piece, flexible, hinged construct) |
| Available sizes | 13 total. 7 MCP (sizes 00, 10, 20, 30, 40, 50, 60). 6 PIP (sizes 0, 1, 2, 3, 4, 5) |
| Resting angulation | 30° at MCP, 15° at PIP (mimics hand-at-rest posture) |
| Flexion / extension range | 0° to 90° |
| In-vitro durability | 10 million flex cycles validated |
| Packaging | Single-use, non-absorbable, sterile |
| Instrumentation sterilisation | Validated at 134°C / 18 min and 134°C / 3 min per ANSI/AAMI ST79 and EN ISO 17665 |
| Regulatory (EU) | CE-marked, EU MDR 2017/745, notified body 1250 |
| Regulatory (US) | FDA 510(k) cleared, K211385, decision date 27 July 2022 |
| Distribution in Cyprus | OrganoGEN Limited |
| GESY reimbursement | Approved (active ZC code) |
Clinical evidence
Longest published series in primary MCP osteoarthritis. 35 patients, mean 8.3-year follow-up (range 2 to 17 years), 97% clinical implant survivorship, mean pain VAS 0.3 of 10 at final review, mean final active flexion arc 4° to 73°.
KeriFlex® implants validated to 10 million flex cycles in vitro across a 0° to 90° flexion-extension range.
Substantial-equivalence clearance for the KeriFlex® MCP and PIP Finger Joint Prostheses, decision date 27 July 2022.
GESY Coverage & Pricing in Cyprus
The KeriFlex® finger implant is GESY-covered when implanted by a participating hand surgeon at a GESY-contracted hospital. The implant cost is included in the hospital reimbursement, and patients are not billed separately for the device.
For self-pay or international patients, OrganoGEN provides hospital quotations on request. Request a quote with your hospital's procurement details.
Frequently asked questions
Which finger joints can KeriFlex® replace?
What is KeriFlex® made of?
Is KeriFlex® CE-marked and FDA-cleared?
What is the durability of the implant?
Is KeriFlex® covered by GESY in Cyprus?
Who manufactures KeriFlex®?
What does recovery look like after KeriFlex® arthroplasty?
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