# K222807: TEMA Elbow system - Line extension

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Oct 26, 2022 after 40 days
- Product code: JDB (Prosthesis, Elbow, Semi-Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3160
- 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: 7 generations back to K883665 (1989). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181362: TEMA Elbow System, Lima Corporate S.P.A. (2019) Summary page 5.

## Recalls of this device
- Oct 2, 2024 · Class II · Z-0744-2025: Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.

## 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 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/K222807
Methodology: https://510kreport.com/methodology