# K071830: Depuy Delta TS Ceramic Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Sep 28, 2007 after 87 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K011533 (2002). 6 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011533: Depuy Femoral Heads, DePuy Orthopaedics, Inc. (2002) Summary page 1.
- K031803: Depuy Ceramic Femoral Heads, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K040644: Modification to Depuy Ceramic Femoral Head, DePuy Orthopaedics, Inc. (2004) Summary page 1.
- K070885: Universal Taper Delta Femoral Head, Howmedica Osteonics Corp. (2007) Summary page 1.
- K051737: Modification to V-40/C-Taper Adapter Sleeve, Howmedica Osteonics Corp. (2005) Summary page 1.
- K052718: V40 Biolox Delta Ceramic Femoral Heads, Howmedica Osteonics Corp. (2005) Summary page 1.

## Most influential descendants
- K073567: Biolox Option Ceramic Femoral Head System, Model 8777 Series (2008), 7 descendants of its own
- K231873: DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional (2024), 5 descendants of its own
- K192416: BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System (2019), 2 descendants of its own
- K251292: RECLAIM Monobloc Revision Femoral Stem (2025), 1 descendant of its own
- K243977: EMPHASYS Acetabular System (2025), 1 descendant of its own

## Recalls of this device
- Nov 7, 2014 · Class II · Z-0825-2015: Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. The loosen

## Indications for use
The DePuy Delta TS Ceramic Hip Head Prosthesis is indicated for use as the femoral head component in total hip arthroplasty procedures. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis.

Source page: https://510kreport.com/device/K071830
Methodology: https://510kreport.com/methodology