# K982981: New Zimmer Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Dec 17, 1998 after 113 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K790987 (1979). 11 ancestors in all.
235 later devices descend from it; 7 cite it directly.
1 of 247 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852137: Fenlin Total Shoulder, Zimmer, Inc. (1986) Summary page 1.
- K870262: Fenlin II Shoulder Prosthesis, Zimmer, Inc. (1987) Summary page 1.
- K790987: Zimmer R Total Shoulder II, Zimmer, Inc. (1979) Summary page 1.
- K895226: Neer II Total Shoulder System & Prosthesis, 3M Company (1989) Summary page 1.
- K920362: 3M Modular Shoulder System, 3M Health Care, Ltd. (1993) Summary page 2.
- K955731: Osteonics Shoulder Humeral Components, Osteonics Corp. (1996) Summary page 2.
- K962082: Osteonics All Polyethylene Glenoid Shoulder Component, Osteonics Corp. (1996) Summary page 2.
- K940537: Kirschner (R) Modular II-C (TM) Total Shoulder System, Kirschner Medical Corp. (1995) Summary page 2.
- K962315: Select Shoulder Cocr Humeral Stem Component, Intermedics Orthopedics (1996) Summary page 2.
- K962238: Select Shoulder Keeled All-Poly Glenoids, Intermedics Orthopedics (1996) Summary page 2.
- K914695: Global Total Shoulder, Depuy, Inc. (1992) Summary page 2.

## Most influential descendants
- K041549: Zimmer Trabecular Metal Humeral Stem (2004), 218 descendants of its own
- K052906: Zimmer Trabecular Metal Reverse Shoulder System (2005), 216 descendants of its own
- K060704: Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM (2006), 207 descendants of its own
- K063569: Equinoxe Reverse Shoulder System (2007), 190 descendants of its own
- K073688: Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw (2008), 177 descendants of its own

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0298-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

## Indications for use
Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; ununited humeral head fractures of long duration; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable.

Source page: https://510kreport.com/device/K982981
Methodology: https://510kreport.com/methodology