# K181307: Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jan 28, 2019 after 256 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: 4 generations back to K001989 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150501: Zimmer Nexel Total Elbow Ulnar Cement Diverter, Zimmer, Inc. (2015) Summary page 5.
- K053189: Coonrad/Morrey Total Elbow, Model 8105 Series, Zimmer, Inc. (2005) Summary page 5.
- K040389: Coonrad/Morrey Elbow Cement Restrictor, Zimmer, Inc. (2004) Summary page 5.
- K001989: Coonrad/Morrey Total Elbow. Model 32-8105 Series, Zimmer, Inc. (2000) Summary page 5.
- K973357: Coonrad/Morrey Total Elbow, New Hinge Pin, Zimmer, Inc. (1998) Summary page 5.

## 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. 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 of joint 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/K181307
Methodology: https://510kreport.com/methodology