VERSYS HIP SYSTEM BEADED HIP PROSTHESIS— 510(k) K973714
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K973714 for VERSYS HIP SYSTEM BEADED HIP PROSTHESIS, Substantially Equivalent on 1997-12-24. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- 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
- Warsaw, IN, US
Recent devices under product code LPH
view allMore clearances from Zimmer, Inc.
view all- K260831 — Z1 Hip System
- K261683 — Augment Off-Axis Instrument System
- K251840 — Zimmer® Persona® Personalized Knee System
- K260182 — Avenir® Müller Stem; Avenir Complete Hip System
- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
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 K973714
K-number listed on FDA's recall record- Z-1022-2018 — VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
- Z-1023-2018 — VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Z-1024-2018 — VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Z-1025-2018 — VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Z-1026-2018 — VERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM 17X160MM LM Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Z-0722-2018 — Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906); b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY STD NECK (Item No. 00784302106); c. VERSYS 6 INCH BEADED FC 22X160MM STD BODY STD NECK (Item No. 00784302206); d. VERSYS 6 INCH BEADED FC STEM 19X160MM LM (Item No. 00784301936); e. VERSYS 6 INCH BEADED FC STEM 20X160MM LM (Item No. 00784302036); f. VERSYS 6 INCH BEADED FC STEM 21X160MM LM (Item No. 00784302136); g. VERSYS 6 INCH BEADED FC STEM 22X160MM LM (Item No. 00784302236); h. VERSYS 6 INCH BEADED FC 14X160MM STD BODY STD NECK (Item No. 00784301406); i. VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK (Item No. 00784301506); j. VERSYS 6 INCH BEADED FC 16X160MM STD BODY STD NECK (Item No. 00784301606); k. VERSYS 6 INCH BEADED FC 17X160MM STD BODY STD NECK (Item No. 00784301706); l. VERSYS 6 INCH BEADED FC 18X160MM STD BODY STD NECK (Item No. 00784301806); m. VERSYS 6 INCH BEADED FC 18X160MM STD BODY EXT NECK (Item No. 00784301826); n. VERSYS 6 INCH BEADED FC 19X160MM STD BODY EXT NECK (Item No. 00784301926); o. VERSYS 6 INCH BEADED FC 20X160MM STD BODY STD NECK (Item No. 00784302006); p. VERSYS 6 INCH BEADED FC 20X160MM STD BODY EXT NECK (Item No. 00784302026); q. VERSYS 6 INCH BEADED FC 21X160MM STD BODY EXT NECK (Item No. 00784302126); r. VERSYS 6 INCH BEADED FC 22X160MM STD BODY EXT NECK (Item No. 00784302226); s. VERSYS 6 INCH BEADED FC 17X160MM LM BODY XEXT NECK (Item No. 00784301746); t. VERSYS 6 INCH BEADED FC 17X160MM LM BODY EXT NECK (Item No. 00784301756 u. VERSYS 6 INCH BEADED FC STEM 18X160MM LM (Item No. 00784301836); v. VERSYS 6 INCH BEADED FC 18X160MM LM BODY XEXT NECK (Item No. 00784301846); w. VERSYS 6 INCH BEADED FC 18X160MM LM BODY EXT NECK (Item No. 00784301856); x. VERSYS 6 INCH BEADED FC 19X160MM LM BODY XEXT NECK (Item No. 00784301946); y. VERSYS 6 INCH BEADED FC 19X160MM LM BODY EXT NECK (Item No. 00784301956); z. VERSYS 6 INCH BEADED FC 20X160MM LM BODY XEXT NECK (Item No. 00784302046); aa. VERSYS 6 INCH BEADED FC 20X160MM LM BODY EXT NECK (Item No. 00784302056); ab. VERSYS 6 INCH BEADED FC 21X160MM LM BODY XEXT NECK (Item No. 00784302146); ac. VERSYS 6 INCH BEADED FC 21X160MM LM BODY EXT NECK (Item No. 00784302156); ad. VERSYS 6 INCH BEADED FC 22X160MM LM BODY XEXT NECK (Item No. 00784302246); ae. VERSYS 6 INCH BEADED FC 22X160MM LM BODY EXT NECK (Item No. 00784302256) Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases that require extensive resection and restoration.
- Z-0848-2016 — VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. " Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected."
- Z-1842-2014 — VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K973714.
Data sourced from openFDA. This site is unofficial and independent of the FDA.