# K242871: ATTUNE™ Revision Hinge Knee

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Nov 21, 2024 after 59 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K896048 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896048: S-Rom/Noiles Mark 3, Joint Medical Products Corp. (1990) Summary page 5.
- K091453: LPS Universal Tibial Hinge Inserts, Model 198727012-198727331, DePuy Orthopaedics, Inc. (2009) Summary page 5.

## Recalls of this device
- May 19, 2026 · Class II · Z-2617-2026: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- May 19, 2026 · Class II · Z-2616-2026: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Apr 3, 2026 · Class II · Z-1988-2026: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Apr 3, 2026 · Class II · Z-1991-2026: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Apr 3, 2026 · Class II · Z-1985-2026: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Apr 3, 2026 · Class II · Z-1990-2026: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Apr 3, 2026 · Class II · Z-1986-2026: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Apr 3, 2026 · Class II · Z-1989-2026: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Apr 3, 2026 · Class II · Z-1987-2026: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Apr 3, 2026 · Class II · Z-1992-2026: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Apr 3, 2026 · Class II · Z-1993-2026: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

## Indications for use
The ATTUNE Revision Hinge Knee is indicated in cases for cement use in patients who have reached skeletal maturity and for whom the surgeon has decided to resect both cruciate ligaments due to the following conditions: 1. Severe instability, gross deformity and/or bone loss 2. Failure of a previous knee reconstruction procedure. 3. Trauma or tumor resection 4. Absent or markedly insufficient collateral ligaments

Source page: https://510kreport.com/device/K242871
Methodology: https://510kreport.com/methodology