Atlas FDA

StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis

FDA 510(k) clearance K160071 · decided 2016-06-16

Clearance details

K-number
K160071
Device name
StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
2016-01-13
Decision date
2016-06-16
Days to decision
155 days
Clearance type
Traditional
Product code
MBB
Device class
2
Regulation number
888.3027
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
SpaceFix Shoulder Spacer (K252443)G21, S.R.L.2025-09-15
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StageOne™ Select Hip Cement Spacer Molds (K222760)Biomet, Inc.2022-12-28
StageOne™ Shoulder Cement Spacer Molds (K221968)Biomet, Inc.2022-09-15
StageOne Knee Cement Spacer Molds (K213287)Biomet, Inc.2022-09-02
SpaceFlex Shoulder (K202338)G21, S.R.L.2021-02-17
SpaceFlex Knee - 80mm Size (K201960)G21, S.R.L.2020-08-13
G21 SpaceFlex Hip (K192041)G21, S.R.L.2019-10-29
SpaceFlex Knee (K190216)G21, S.R.L.2019-06-09
StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis (K161273)Biomet, Inc.2017-01-25
StageOne Select Cement Spacer Molds for Temporary Hip Replacement (K161166)Biomet, Inc.2016-09-08

Recalls involving this device

RecordFirmDate
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Ite recall (Z-1657-2020)Biomet, Inc.2020-04-03
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Ite recall (Z-1658-2020)Biomet, Inc.2020-04-03
BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, It recall (Z-1659-2020)Biomet, Inc.2020-04-03
BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, It recall (Z-1660-2020)Biomet, Inc.2020-04-03
BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, It recall (Z-1661-2020)Biomet, Inc.2020-04-03

PMA approvals by this applicant

RecordFirmDate
C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009)Biomet, Inc.2011-02-11
C2A-TAPER ACETABULAR SYSTEM (P050009/S004)Biomet, Inc.2009-04-17
C2A TAPER ACETABULAR SYSTEM (P050009/S007)Biomet, Inc.2009-03-13
C2-A TAPER ACETABULAR SYSTEM (P050009/S005)Biomet, Inc.2007-11-30
C2A-TAPER ACETABULAR SYSTEM (P050009/S002)Biomet, Inc.2006-06-16
C2A-TAPER ACETABULAR SYSTEM (P050009/S001)Biomet, Inc.2006-02-01
C2 A-TAPER ACETABULAR SYSTEM (P050009)Biomet, Inc.2005-12-16