# K934765: Trilogy Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Apr 29, 1994 after 206 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
391 later devices descend from it; 12 cite it directly.
0 of 392 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K021891: Zimmer Trabecular Metal Modular Acetabular System (2002), 248 descendants of its own
- K091508: Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System (2009), 246 descendants of its own
- K990135: Trilogy Acetabular System Longevity Crosslinked Polyethylene (1999), 192 descendants of its own
- K993082: Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular Component (1999), 161 descendants of its own
- K041906: Exactech 12/14 Total Hip System (2004), 145 descendants of its own

## Recalls of this device
- May 4, 2016 · Class II · Z-1684-2016: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Jan 11, 2016 · Class II · Z-1145-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jan 11, 2016 · Class II · Z-1123-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jan 11, 2016 · Class II · Z-1161-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jan 11, 2016 · Class II · Z-1115-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Dec 4, 2014 · Class II · Z-0875-2015: Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. Subsequent investigation found the polar-hole t
- Nov 21, 2014 · Class II · Z-0824-2015: Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of the fractures. .
- Jun 12, 2014 · Class II · Z-2032-2014: Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot numbe
- Oct 11, 2013 · Class II · Z-1024-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag
- Sep 14, 2012 · Class II · Z-0771-2013: Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded 
- Sep 14, 2012 · Class II · Z-0773-2013: Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded 
- Sep 14, 2012 · Class II · Z-0769-2013: Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded 
- Sep 14, 2012 · Class II · Z-0775-2013: Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded 
- Sep 14, 2012 · Class II · Z-0772-2013: Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded 
- Oct 19, 2007 · Not classified · Z-0620-2008: Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim.
- Jun 26, 2006 · Not classified · Z-1344-06: Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.

Source page: https://510kreport.com/device/K934765
Methodology: https://510kreport.com/methodology