# P980052: TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis

- Pathway: PMA
- Applicant: TMJ Concepts
- Decided: Jul 2, 1999 after 177 days
- Product code: LZD (Joint, Temporomandibular, Implant)
- Device class: 3
- Regulation: 21 CFR 872.3940
- Recalls of this device: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Feb 11, 2026 · Class II · Z-2524-2026: Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.
- Oct 13, 2025 · Class I · Z-0488-2026: Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
- Dec 6, 2022 · Class II · Z-1234-2023: Device was shipped without having regulatory approval.
- Mar 12, 2018 · Class II · Z-1444-2018: This device was mislabeled and is not the correct component for this patient.

Source page: https://510kreport.com/device/P980052
Methodology: https://510kreport.com/methodology