# K053189: Coonrad/Morrey Total Elbow, Model 8105 Series

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Dec 9, 2005 after 24 days
- Product code: JDC (Prosthesis, Elbow, Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3150
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001989 (2000). 1 ancestor in all.
8 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001989: Coonrad/Morrey Total Elbow. Model 32-8105 Series, Zimmer, Inc. (2000) Summary page 1.

## Most influential descendants
- K171010: Latitude EV Total Elbow Arthroplasty (2017), 4 descendants of its own
- K123862: Zimmer Nexel Total Elbow (2013), 4 descendants of its own
- K181362: TEMA Elbow System (2019), 1 descendant of its own
- K182461: LATITUDE EV Total Elbow Arthroplasty (2018), 1 descendant of its own
- K150501: Zimmer Nexel Total Elbow Ulnar Cement Diverter (2015), 1 descendant of its own

## Recalls of this device
- Jan 30, 2009 · Not classified · Z-1056-2009: The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone.
- Jan 30, 2009 · Not classified · Z-1055-2009: The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone.

## Indications for use
Indications include: 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; revision arthroplasty, and 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. Patient 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/K053189
Methodology: https://510kreport.com/methodology