# K980502: Osteonics Total Elbow System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: May 5, 1998 after 85 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Osteonics® Linked Semi-Constrained Total Elbow Prosthesis: named in the summary without a submission number

## Most influential descendants
- K181362: TEMA Elbow System (2019), 1 descendant of its own
- K222807: TEMA Elbow system - Line extension (2022), 0 descendants of its own
- K983036: Single Axle Total Elbow (1999), 0 descendants of its own

## Recalls of this device
- Jul 30, 2026 · Class II · Z-3195-2026: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which m

## Indications for use
The indications for the Osteonics® Total Elbow System, in keeping with the legally marketed Osteonics® Linked Constrained Total Elbow Prosthesis, are as follows: o Painful, disabling joint disease of the elbow resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. ® Distal humeral fracture and/or dislocation. ° Revision of previous unsuccessful total elbow replacement, resurfacing, or other procedure. ° Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. o The Osteonics® Total Elbow System is indicated for cemented use only.

Source page: https://510kreport.com/device/K980502
Methodology: https://510kreport.com/methodology