Genesis Constrained System (GCS)
by Smith & Nephew Richards, Inc. 510(k)
Active
510(k) K952271
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK952271 | Date8 Sep 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JWH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3560
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Genesis Constrained System (GCS) is a constrained knee implant classified under the FDA product code JWH as an orthopedic device. It is designed to provide internal stability and constrained motion for knee arthroplasty procedures, particularly in cases requiring enhanced rotational control and ligamentous support. This device is intended for use in total or partial knee replacements where standard implants may not offer sufficient stability.
The GCS is supplied as a surgical implant system and is intended for single-use in orthopedic procedures. It is regulated under FDA 510(k) clearance (K952271) and is substantiated as substantially equivalent to predicate devices with a history of market use. The system is not described as MRI-safe or reusable, and no specific sterility or storage conditions are noted in the regulatory data. Distribution is managed by Smith & Nephew Richards, Inc., with no additional regulatory approvals mentioned beyond the 510(k) clearance.
Other devices from Smith & Nephew Richards, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Genesis Constrained System (GCS) used for?
The Genesis Constrained System (GCS) is designed for knee arthroplasty procedures, specifically total or partial knee replacements where standard implants may not provide adequate stability. It is intended to offer internal stability and constrained motion, making it suitable for cases requiring enhanced rotational control and ligamentous support.
Is the Genesis Constrained System (GCS) single-use or reusable?
The Genesis Constrained System (GCS) is intended for single-use in orthopedic procedures. This is a standard practice for surgical implants to ensure sterility and patient safety, reducing the risk of cross-contamination between patients.
What regulatory approval does the Genesis Constrained System (GCS) hold?
The Genesis Constrained System (GCS) holds FDA 510(k) clearance under the reference number K952271. This clearance indicates that the device is substantially equivalent to a predicate device with a history of market use, meeting regulatory standards for safety and effectiveness.
Does the Genesis Constrained System (GCS) come with specific storage instructions?
The regulatory data for the Genesis Constrained System (GCS) does not specify any particular sterility or storage conditions. However, as a surgical implant, it should be stored in accordance with standard orthopedic device protocols to maintain its integrity and sterility until use.
Who distributes the Genesis Constrained System (GCS)?
The Genesis Constrained System (GCS) is distributed by Smith & Nephew Richards, Inc. This manufacturer manages the distribution and ensures compliance with regulatory requirements, including the FDA 510(k) clearance.