# K990667: KLS-Martin Temporary Condylar Implant

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Jul 27, 2001 after 878 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
No predicates in its family tree.
437 later devices descend from it; 3 cite it directly.
0 of 438 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) Leibinger Temporary Condylar Implant: named in the summary without a submission number

## Most influential descendants
- K032442: KLS-Martin Mandibular/Reconstruction System II (2003), 435 descendants of its own
- K040598: KLS Martin Hand Plating System (2004), 360 descendants of its own
- K050868: Maxlock (2005), 343 descendants of its own
- K073624: Modular Foot System (2008), 342 descendants of its own
- K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology (2010), 339 descendants of its own

## Indications for use
The KLS-Martin Temporary Condylar Implant is only intended 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 for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).

Source page: https://510kreport.com/device/K990667
Methodology: https://510kreport.com/methodology