Atlas FDA

COMPREHENSIVE PRIMARY SHOULDER STEMS

FDA 510(k) clearance K060692 · decided 2006-05-30

Clearance details

K-number
K060692
Device name
COMPREHENSIVE PRIMARY SHOULDER STEMS
Applicant
Biomet Manufacturing Corp
Decision
Substantially Equivalent
Date received
2006-03-15
Decision date
2006-05-30
Days to decision
76 days
Clearance type
Traditional
Product code
MBF
Device class
2
Regulation number
888.3670
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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PRIMA Humeral System; PRIMA TT Glenoid (K233712)Lima Corporate S.P.A.2024-01-11
SMR Hybrid Glenoid System (K231099)Lima Corporate S.P.A.2023-12-21
INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid (K230831)Depuy Ireland UC2023-11-13
INHANCE™ Shoulder System, Sterile Single Use Instrumentation (K231516)Depuy Ireland UC2023-07-21
SMR Shoulder System (K223876)Lima Corporate S.P.A.2023-02-03
PRIMA TT Glenoid (K222427)Lima Corporate S.P.A.2022-10-06
Identity Shoulder System (K213856)Zimmer, Inc.2022-09-15
INHANCETM Hybrid Anatomic Glenoid Implant (K212933)Depuy Ireland UC2022-06-08

Recalls involving this device

RecordFirmDate
Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: Th recall (Z-1543-2020)Biomet, Inc.2020-03-03
Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standa recall (Z-1755-2015)Biomet, Inc.2015-06-11

PMA approvals by this applicant

RecordFirmDate
Oxford™ Knee System (P010014/S111)Biomet Manufacturing Corp2025-08-07
Oxford Partial Knee System (P010014/S109)Biomet Manufacturing Corp2025-08-07
OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S110)Biomet Manufacturing Corp2025-06-24
Oxford® Partial Knee System (P010014/S107)Biomet Manufacturing Corp2024-11-22
Oxford™ Cementless Partial Knee System (P010014/S105)Biomet Manufacturing Corp2024-11-22
Oxford Partial Knee System (P010014/S108)Biomet Manufacturing Corp2024-11-18
Oxford® Partial Knee System (P010014/S106)Biomet Manufacturing Corp2024-08-19
Oxford Partial Knee (P010014/S104)Biomet Manufacturing Corp2023-04-06