NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5— 510(k) K113609

Name: FDA 510(k) clearance K113609
Creator: U.S. Food and Drug Administration
Published: 2012-01-04

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K113609 for NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5, Substantially Equivalent on 2012-01-04. Applicant: Exactech, Inc.. Device class: 2.

Clearance details

Applicant: Exactech, Inc.
Product code: Product code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2011-12-06
Decision date: 2012-01-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LPH

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K261453 — G7® Acetabular System2026-09-23
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K254043 — TRIVANCE Hip Stem2026-08-04
K261624 — Omnifit® 20° Series I Insert +11 more2026-07-10
K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating2026-06-05

More clearances from Exactech, Inc.

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K260583 — Equinoxe® Shoulder System2026-04-14
K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants2025-12-01
K243448 — Equinoxe® Shoulder System2025-08-01
K243275 — Equinoxe® Scapula Fracture System2025-06-26
K243839 — Alteon® HA Femoral Stems2025-03-10

Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K113609

K-number listed on FDA's recall record

Z-0906-2014 — ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. 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.Class II·Terminated·Exactech, Inc.·20130911

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113609.

Data sourced from openFDA. This site is unofficial and independent of the FDA.