# K181362: TEMA Elbow System

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Feb 16, 2019 after 269 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: 6 generations back to K883665 (1989). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 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 5.
- K053189: Coonrad/Morrey Total Elbow, Model 8105 Series, Zimmer, Inc. (2005) Summary page 5.
- K100562: Latitude Elbow Prosthesis, Tornier, Inc. (2010) Summary page 5.
- K171010: Latitude EV Total Elbow Arthroplasty, Tornier, Inc. (2017) Summary page 5.
- K980502: Osteonics Total Elbow System, Osteonics Corp. (1998) Summary page 5.
- K013042: Discovery Elbow, Biomet Orthopedics, Inc. (2001) Summary page 5.
- K051975: Porous Coated Discovery Elbow, Biomet, Inc. (2005) Summary page 5.
- K090473: Discovery Elbow - X-Small, Biomet Manufacturing Corp (2009) Summary page 5.
- K123862: Zimmer Nexel Total Elbow, Zimmer, Inc. (2013) Summary page 5.

## Most influential descendants
- K222807: TEMA Elbow system - Line extension (2022), 0 descendants of its own

## Recalls of this device
- Jan 25, 2023 · Class II · Z-1261-2023: Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.

## Indications for use
TEMA Elbow System is intended for use in cemented applications for patients suffering from disability due to: 1. Elbow joint destruction which significantly compromises the activities of daily living 2. Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia. 3. Rheumatoid arthritis or degenerative arthritis with incapacitating pain 4. Revision where other devices or treatments have failed. 5. Correction of severe functional deformity. 6. Treatment of acute or chronic fractures with distal humerus epicondyle involvement. 7. Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion The unlinked, semi-constrained version is intended for use in cases where there are functioning medial and lateral elbow ligaments of good quality that provide immediate stability, resisting any tendency of dislocation or disengagement between ulnar and humeral components, when intraoperative manual testing is performed.

Source page: https://510kreport.com/device/K181362
Methodology: https://510kreport.com/methodology