# K001989: Coonrad/Morrey Total Elbow. Model 32-8105 Series

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Jul 25, 2000 after 26 days
- Product code: JDC (Prosthesis, Elbow, Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3150
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K053189: Coonrad/Morrey Total Elbow, Model 8105 Series (2005), 8 descendants of its own
- 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

## Recalls of this device
- Dec 12, 2019 · Class II · Z-1000-2020: The lot contained two outer pins instead of one outer and one inner pin.
- Oct 10, 2019 · Class II · Z-0301-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Jan 24, 2018 · Class II · Z-1239-2018: One lot of humeral stem implants do not include the humeral bushing components.
- Aug 16, 2016 · Class II · Z-2752-2016: Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small because the lot was packaged with a missing hum
- Nov 19, 2012 · Class II · Z-0538-2013: 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
- Jan 30, 2009 · Not classified · Z-1053-2009: 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-1054-2009: 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-1057-2009: 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-1058-2009: The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone.
- Mar 16, 2004 · Not classified · Z-0767-04: Right ulna implants were etched and labeled as left ulna implants. Left ulna implants may have been etched and labeled as right ulna implants.

Source page: https://510kreport.com/device/K001989
Methodology: https://510kreport.com/methodology