# K973357: Coonrad/Morrey Total Elbow, New Hinge Pin

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Mar 2, 1998 after 175 days
- Product code: JDC (Prosthesis, Elbow, Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3150
- 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 K883665 (1989). 1 ancestor in all.
10 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883665: Coonrad Iii Total Elbow, Zimmer, Inc. (1989) Summary page 2.

## Most influential descendants
- K050848: Tornier Elbow Prosthesis (2005), 7 descendants of its own
- K031218: Modification to Tornier Total Elbow Prosthesis (2003), 7 descendants of its own
- K070787: Latitude Elbow Prothesis (2007), 6 descendants of its own
- K100562: Latitude Elbow Prosthesis (2010), 5 descendants of its own
- K171010: Latitude EV Total Elbow Arthroplasty (2017), 4 descendants of its own

## Recalls of this device
- Nov 19, 2012 · Class II · Z-0537-2013: Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the Ne

## Indications for use
Post-traumatic lesions or bone loss contributing to elbow instability Ankylosed joints, especially in cases of bilateral ankylosis from causes other than sepsis Advanced rheumatoid or degenerative arthritis with incapacitating pain Instability or loss of motion when the degree of joint damage precludes less radical procedures The candidate for total elbow arthroplasty should exhibit joint destruction which significantly compromises the activities of daily living. Patients with single joint involvement (generally those with traumatic or degenerative arthritis) or significant lower extremity disability which require walking aids are less amenable to treatment than patients with advanced and predominantly upper extremity involvement. If possible, elbow replacement should be done after hip or knee surgery to avoid excessive stress to the prosthesis required by crutch walking during total hip or knee rehabilitation.

Source page: https://510kreport.com/device/K973357
Methodology: https://510kreport.com/methodology