# K150496: Total Knee Arthroplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Responsive Orthopedics, LLC
- Decided: Jun 12, 2015 after 107 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: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K943462 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943462: Darwin Knee System, Johnson & Johnson Professionals, Inc. (1994) Summary page 4.
- K961685: P.F.C. Cruciate Retaining Knee System (Size 1.5), Johnson & Johnson Professionals, Inc. (1996) Summary page 4.
- K032151: Depuy Sigma Tibial Inserts and CO-CR Tibial Trays, Depuy, Inc. (2003) Summary page 4.
- K950010: Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated, Johnson & Johnson Professionals, Inc. (1995) Summary page 4.
- K093552: Evolution MP Total Knee System, Wrightmedicaltechnologyinc (2010) Summary page 4.
- K932837: Consensus Knee System - Primary Knee, U.S. Medical Products, Inc. (1994) Summary page 4.

## Recalls of this device
- Feb 20, 2017 · Class II · Z-1515-2017: The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
- Feb 20, 2017 · Class II · Z-1513-2017: The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
- Feb 20, 2017 · Class II · Z-1516-2017: The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
- Feb 20, 2017 · Class II · Z-1514-2017: The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
- Jul 18, 2016 · Class II · Z-2636-2016: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
- Jul 18, 2016 · Class II · Z-2637-2016: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
- Jul 18, 2016 · Class II · Z-2635-2016: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
- Jul 18, 2016 · Class II · Z-2634-2016: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
- Jul 18, 2016 · Class II · Z-2631-2016: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
- Jul 18, 2016 · Class II · Z-2638-2016: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
- Jul 18, 2016 · Class II · Z-2633-2016: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
- Jul 18, 2016 · Class II · Z-2632-2016: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

## Indications for use
The Responsive Orthopedics Total Knee Arthroplasty System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; inflammatory degenerative joint disease including rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The Responsive Orthopedics Total Knee Arthroplasty System is for cemented use only.

Source page: https://510kreport.com/device/K150496
Methodology: https://510kreport.com/methodology