Arcos One-piece Femoral Revision System

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

Biomet, Inc.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Arcos One-piece Femoral Revision System.

Pre-market Notification Details

• Device ID: K151603
• 510k Number: K151603
• Device Name: Arcos One-piece Femoral Revision System
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: Biomet, Inc. 56 East Bell Drive.P.O.Box 587 Warsaw, IN 46581
• Contact: Tracy Johnson
• Correspondent: Paul Cutlan; BIOMET UK LTD. WATERTON INDUSTRIAL ESTATE Bridgend, GB Cf31 3xa
• Product Code: LPH
• Subsequent Product Code: JDI
• Subsequent Product Code: KWL
• Subsequent Product Code: KWY
• Subsequent Product Code: KWZ
• Subsequent Product Code: LWJ
• Subsequent Product Code: LZO
• Subsequent Product Code: OQG
• Subsequent Product Code: OQH
• Subsequent Product Code: OQI
• Subsequent Product Code: PBI
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-06-12
• Decision Date: 2015-10-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304688537	K151603	000
00880304683280	K151603	000
00880304683273	K151603	000
00880304683266	K151603	000
00880304683259	K151603	000
00880304683242	K151603	000
00880304683235	K151603	000
00880304683228	K151603	000
00880304683211	K151603	000
00880304683204	K151603	000
00880304683198	K151603	000
00880304683181	K151603	000
00880304683174	K151603	000
00880304683167	K151603	000
00880304683150	K151603	000
00880304684690	K151603	000
00880304684706	K151603	000
00880304684713	K151603	000
00880304688520	K151603	000
00880304688513	K151603	000
00880304688506	K151603	000
00880304688490	K151603	000
00880304688483	K151603	000
00880304688476	K151603	000
00880304688469	K151603	000
00880304688452	K151603	000
00880304688445	K151603	000
00880304688438	K151603	000
00880304688421	K151603	000
00880304688407	K151603	000
00880304684928	K151603	000
00880304684782	K151603	000
00880304683143	K151603	000
00880304683136	K151603	000
00880304683112	K151603	000
00887868469367	K151603	000
00887868469350	K151603	000
00887868469343	K151603	000
00887868469336	K151603	000
00887868469329	K151603	000
00887868469312	K151603	000
00887868469305	K151603	000
00887868469299	K151603	000
00887868469282	K151603	000
00887868469275	K151603	000
00887868469268	K151603	000
00887868469251	K151603	000
00887868469244	K151603	000
00887868469237	K151603	000
00887868469374	K151603	000
00887868469381	K151603	000
00887868469398	K151603	000
00887868469534	K151603	000
00887868469527	K151603	000
00887868469510	K151603	000
00887868469503	K151603	000
00887868469497	K151603	000
00887868469480	K151603	000
00887868469473	K151603	000
00887868469466	K151603	000
00887868469459	K151603	000
00887868469442	K151603	000
00887868469435	K151603	000
00887868469428	K151603	000
00887868469411	K151603	000
00887868469404	K151603	000
00887868469220	K151603	000
00880304691629	K151603	000
00880304691018	K151603	000
00880304691001	K151603	000
00880304690998	K151603	000
00880304690981	K151603	000
00880304690974	K151603	000
00880304690967	K151603	000
00880304690950	K151603	000
00880304690943	K151603	000
00880304690936	K151603	000
00880304690929	K151603	000
00880304690912	K151603	000
00880304690905	K151603	000
00880304690899	K151603	000
00880304690875	K151603	000
00880304691025	K151603	000
00880304691032	K151603	000
00880304691469	K151603	000
00880304691612	K151603	000
00880304691605	K151603	000
00880304691599	K151603	000
00880304691582	K151603	000
00880304691575	K151603	000
00880304691568	K151603	000
00880304691551	K151603	000
00880304691544	K151603	000
00880304691537	K151603	000
00880304691520	K151603	000
00880304691513	K151603	000
00880304691506	K151603	000
00880304691490	K151603	000
00880304691483	K151603	000
00880304689244	K151603	000
00880304689237	K151603	000
00880304689220	K151603	000
00880304688698	K151603	000
00880304688681	K151603	000
00880304688674	K151603	000
00880304688667	K151603	000
00880304688650	K151603	000
00880304688643	K151603	000
00880304688636	K151603	000
00880304688629	K151603	000
00880304688612	K151603	000
00880304688605	K151603	000
00880304688599	K151603	000
00880304688575	K151603	000
00880304688568	K151603	000
00880304688551	K151603	000
00880304688704	K151603	000
00880304688711	K151603	000
00880304688728	K151603	000
00880304689213	K151603	000
00880304689206	K151603	000
00880304689190	K151603	000
00880304689183	K151603	000
00880304689176	K151603	000
00880304689169	K151603	000
00880304689152	K151603	000
00880304689145	K151603	000
00880304689138	K151603	000
00880304689121	K151603	000
00880304689114	K151603	000
00880304689107	K151603	000
00880304689084	K151603	000
00880304688735	K151603	000
00880304688544	K151603	000