# K113609: Novation Integrip Acetabular Augments, Groups 4 and 5

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Jan 4, 2012 after 29 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
Longest line of descent: 1 generation back to K101761 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101761: Exactech Novation Empire Acetabular Augment with Integrip Model 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13, Exactech, Inc. (2010) Summary page 1.

## 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 Exactech Novation InteGrip 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 Exactech Novation InteGrip Acetabular Augment is affixed to the mating acetabular shell using PMMA bone cement. Therefore, acetabular shells with HA coating must not be used with InteGrip Acetabular Augments. The assembled construct is intended for press-fit fixation.

Source page: https://510kreport.com/device/K113609
Methodology: https://510kreport.com/methodology