# K123862: Zimmer Nexel Total Elbow

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Mar 12, 2013 after 88 days
- Product code: JDC (Prosthesis, Elbow, Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001989 (2000). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 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.
- K053189: Coonrad/Morrey Total Elbow, Model 8105 Series, Zimmer, Inc. (2005) Summary page 1.

## Most influential descendants
- K181362: TEMA Elbow System (2019), 1 descendant of its own
- K150501: Zimmer Nexel Total Elbow Ulnar Cement Diverter (2015), 1 descendant of its own
- K222807: TEMA Elbow system - Line extension (2022), 0 descendants of its own
- K181307: Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow (2019), 0 descendants of its own

## Indications for use
Indications for use include: - Elbow joint destruction which significantly compromises the activities of daily living - Post-traumatic lesions or bone, loss contributing to elbow instability - Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis - Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain - Instability or loss of motion when the degree ofjoint or soft tissue damage precludes reliable osteosynthesis - Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus - Revision arthroplasty CAUTION: This device is intended for cemented use only.

Source page: https://510kreport.com/device/K123862
Methodology: https://510kreport.com/methodology