NOVATION CROWN CUP GXL LINERS— 510(k) K100269

Name: FDA 510(k) clearance K100269
Creator: U.S. Food and Drug Administration
Published: 2010-05-27

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K100269 for NOVATION CROWN CUP GXL LINERS, Substantially Equivalent on 2010-05-27. Applicant: Exactech, Inc.. Device class: 2.

Clearance details

Applicant: Exactech, Inc.
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2010-01-29
Decision date: 2010-05-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

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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 K100269

K-number listed on FDA's recall record

Z-1731-2022 — GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;Class II·Ongoing·Exactech, Inc.·20220811
Z-2115-2021 — Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Liner, G00, 22mm ID. Orthopedic hip implant component.Class II·Ongoing·Exactech, Inc.·20210629
Z-2120-2021 — Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant, 28mm. Orthopedic hip implant component.Class II·Ongoing·Exactech, Inc.·20210629
Z-2121-2021 — Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID; Novation GXL Liner, Lipped Ant, 28mm; and Novation GXL Liner, Lipped, 28mm. Orthopedic hip implant component.Class II·Ongoing·Exactech, Inc.·20210629
Z-2125-2021 — Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-22-XX, Novation GXL Liner, +5mm Lateralized, G00, 22mm ID. Orthopedic hip implant component.Class II·Ongoing·Exactech, Inc.·20210629
Z-2130-2021 — Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm ID. Orthopedic hip implant component.Class II·Ongoing·Exactech, Inc.·20210629
Z-2131-2021 — Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Novation GXL Liner, 10 Deg Face, 28mm. Orthopedic hip implant component.Class II·Ongoing·Exactech, Inc.·20210629

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100269.

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