# K953653: Lubinus SP II Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Turnkey Intergration USA, Inc.
- Decided: Nov 6, 1995 after 95 days
- Product code: JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: 5 (0 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.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jul 15, 2025 · Class II · Z-2288-2025: Inconsistent size terminology and color coding used on labeling
- Feb 6, 2024 · Class II · Z-1299-2024: Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surg
- Feb 6, 2024 · Class II · Z-1297-2024: Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surg
- Feb 6, 2024 · Class II · Z-1298-2024: Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surg
- Feb 6, 2024 · Class II · Z-1296-2024: Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surg

Source page: https://510kreport.com/device/K953653
Methodology: https://510kreport.com/methodology