Atlas FDA

UNITED UTF STEM

FDA 510(k) clearance K110245 · decided 2011-08-04

Clearance details

K-number
K110245
Device name
UNITED UTF STEM
Applicant
United Orthopedic Corporation
Decision
Substantially Equivalent
Date received
2011-01-27
Decision date
2011-08-04
Days to decision
189 days
Clearance type
Traditional
Product code
LPH
Device class
2
Regulation number
888.3358
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Hsinchu, TW
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch United Orthopedic Corporation

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
TRIVANCE™ Hip Stem (K254043)Globus Medical, Inc.2026-08-04
Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component (K261624)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2026-07-10
iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating (K243192)Nextstep Arthopedix, LLC2026-06-05
Taperloc® Complete Hip Stem (K251270)Biomet, Inc.2026-05-19
G7® Revision Acetabular System (K252623)Zimmer, Inc.2026-02-04
Mpact 3D Metal Implants Extension – DMLS Technology (K251043)Medacta International S.A.2026-01-28
Velora Acetabular System (K252067)Restor3D, Inc.2025-12-05
TaperSet™ Hip System (K252846)Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics2025-11-20
EMPOWR Acetabular® Liner Extension (K251833)Encore Medical L.P.2025-11-12
ArTT Augments and Buttresses and Bone Screws (K251718)Lima Corporate S.P.A.2025-08-29
Stryker and Serf hip devices (K250989)Howmedica Osteonics Corp (Dba Stryker Orthopaedics)2025-07-25
ONVOY™ Acetabular System (K243456)Globus Medical, Inc.2025-06-06

Recalls involving this device

RecordFirmDate
Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimuel recall (Z-1385-2013)Orthopedic Alliance LLC2013-05-24