BIOLOX DELTA CERAMIC FEMORAL HEAD— 510(k) K071535
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K071535 for BIOLOX DELTA CERAMIC FEMORAL HEAD, Substantially Equivalent on 2007-11-19. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Code LZO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3353
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code LZO
view allMore clearances from Zimmer, Inc.
view all- K261683 — Augment Off-Axis Instrument System
- K251840 — Zimmer® Persona® Personalized Knee System
- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
- K253566 — Affixus Retrograde Femoral Nailing System
- K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
Adverse events under product code LZO
product code LZO- Death
- 17
- Injury
- 12,942
- Malfunction
- 1,756
- Total
- 14,715
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 K071535
K-number listed on FDA's recall record- Z-0336-2020 — Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 00877504003 00877504004
- Z-1134-2015 — Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem components in total hip arthroplasty. A variety of sizes and neck lengths are available for various patient anatomies and adjustment of the tension of the ligaments and reconstruction of the center of the natural head of the femur.
- Z-0211-2013 — Biolox¿ delta Ceramic Femoral Head Rx only, sterile
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071535.
Data sourced from openFDA. This site is unofficial and independent of the FDA.