HIP SYSTEMS— 510(k) K121308
Substantially EquivalentHowmedica Osteonics Corp.
FDA 510(k) clearance K121308 for HIP SYSTEMS, Substantially Equivalent on 2012-07-30. Applicant: Howmedica Osteonics Corp.. Device class: 2.
Clearance details
- Applicant
- Howmedica Osteonics Corp.
- Product code
- Code LPH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
Recent devices under product code LPH
view allMore clearances from Howmedica Osteonics Corp.
view all- K193429 — Exeter V40 Femoral Stem, Exeter X3 RimFit Cup
- K200782 — Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite
- K130895 — REUNION RSA SHOULDER SYSTEM
- K123604 — ABG III MONOLITHIC HIP STEM
- K122015 — DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
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, through . 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 K121308
K-number listed on FDA's recall record- Z-0651-2022 — Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044
- Z-0652-2022 — Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440
- Z-0644-2022 — 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
- Z-0514-2020 — Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
- Z-0940-2018 — Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
- Z-0941-2018 — Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535
- Z-0261-2016 — Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121308.
Data sourced from openFDA. This site is unofficial and independent of the FDA.