Atlas FDA

COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE

FDA 510(k) clearance K033506 · decided 2004-02-02

Clearance details

K-number
K033506
Device name
COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
2003-11-05
Decision date
2004-02-02
Days to decision
89 days
Clearance type
Traditional
Product code
KWS
Device class
2
Regulation number
888.3660
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Biomet

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
Tornier Perform Advanced Glenoid (K260721)Tornier, Inc.2026-07-22
AETOS Shoulder System - CONCELOC Glenoids (K254084)Smith & Nephew, Inc.2026-04-06
Catalyst F1x Shoulder System (K252418)Catalyst Orthoscience, Inc.2025-11-06
AETOS Shoulder System Meta Humeral Prosthesis Size 0 (K252416)Smith & Nephew, Inc.2025-10-29
MyShoulder Planner (5.3SSWPL) (K241292)Medacta International S.A.2025-01-30
Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) (K241878)Stryker Corporation (Tornier, Inc.)2024-12-06
Tornier Humeral Reconstruction System (Tornier HRS) (K241609)Stryker Corporation (Tornier, Inc.)2024-09-10
Arthrex Univers Apex OptiFit Humeral Stem (K230513)Arthrex, Inc.2023-09-26
AltiVate® Anatomic Shoulder AG e+™ with Markers (K222592)Encore Medical L.P.2023-06-23
AETOS Shoulder System (K230572)Smith & Nephew, Inc.2023-06-07
AETOS Shoulder System (K220847)Smith & Nephew, Inc.2023-01-03
Catalyst EA Convertible Stemmed Shoulder (K222317)Catalyst Orthoscience, Inc.2022-11-10

Recalls involving this device

No recalls on record reference this clearance.

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