# K031701: Osteomed Temporary Condylar Attachment System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Jul 8, 2004 after 402 days
- Product code: NEI (Prosthesis, Condyle, Mandibular, Temporary)
- Device class: 2
- Regulation: 21 CFR 872.4770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000594 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990667: KLS-Martin Temporary Condylar Implant, KLS-Martin L.P. (2001) Summary page 1.
- K002790: Add-on Condyle, Walter Lorenz Surgical, Inc. (2001) Summary page 1.
- K000594: Locking Screw Mandibular Reconstruction Plate, Stryker Leibinger (2000) Summary page 1.

## Indications for use
Indicated for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign tumors requiring the removal of the mandibular condyle. This device is not intended for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). Implants are intended for single patient use.

Source page: https://510kreport.com/device/K031701
Methodology: https://510kreport.com/methodology