# K101761: Exactech Novation Empire Acetabular Augment with Integrip Model 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Sep 21, 2010 after 90 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K001471: The Implex Hedrocel Acetabular Augment, XX-Yyy-ZZZZ, Implex Corp. (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K113609: Novation Integrip Acetabular Augments, Groups 4 and 5 (2012), 0 descendants of its own

## Recalls of this device
- Sep 11, 2013 · Class II · Z-0906-2014: Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard.

## Indications for use
The Empire Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip replacement and whose orthopedic surgeon desires a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies. The Empire Acetabular Augment is affixed to the mating acetabular shell using PMMA bone cement. Therefore, acetabular shells with HA coating must not be used with Empire Acetabular Augments. The assembled construct is intended for press-fit fixation. The construct may also be used with bone cement at the discretion of the surgeon.

Source page: https://510kreport.com/device/K101761
Methodology: https://510kreport.com/methodology