# K140222: Saiph Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Matortho
- Decided: Nov 17, 2014 after 292 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K830726 (1983). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020214: Medial Rotation Knee System, Engineering Consulting Services, Inc. (2002) Summary page 4.
- K023211: Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components, Zimmer, Inc. (2002) Summary page 4.
- K003910: Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate Retaining (CR) Articular Surface Components, Zimmer, Inc. (2001) Summary page 4.
- K963148: Nexgen Complete Knee Solution, Zimmer, Inc. (1997) Summary page 4.
- K031729: Triathlon Posteriorly Stabilized (PS) Total Knee System, Howmedica Osteonics Corp. (2003) Summary page 4.
- K935080: Insall-Burstein II, Hospital For Special Surgery (1995) Summary page 4.
- K931466: PFC Modular Total Knee System, Porous Coated Sacri, Johnson & Johnson Orthopaedics, Inc. (1994) Summary page 4.
- K946088: Genesis Posterior Stabilized (P/S) Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 4.
- K932070: Duracon Stabilizer Femoral Component and Insert, Howmedica Corp. (1995) Summary page 5.

## Indications for use
The Saiph® Knee System is intended for cemented only in the U.S. It is intended for single use in total knee arthroplasty surgery for the reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: I. Non-inflammatory degenerative Joint disease resulting from osteoarthritis, traumatic arthritis and avascular necrosis; 2. Inflammatory degenerative joint disease including rheumatoid arthritis: 3. Correction of varus, valgus, or post traumatic deformity; 4. Correction or revision of unsuccessful osteotomy or arthrodesis: 5. Revision procedures where other treatments or devices have failed; and 6. Treatment of fractures that are unmanageable using other techniques.

Source page: https://510kreport.com/device/K140222
Methodology: https://510kreport.com/methodology