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ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device

FDA 510(k) clearance K222971 · decided 2023-02-17

Clearance details

K-number
K222971
Device name
ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2022-09-27
Decision date
2023-02-17
Days to decision
143 days
Clearance type
Traditional
Product code
MBI
Device class
2
Regulation number
888.3040
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Andover, MA, 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
Grappler Suture Anchor System (K262047)Paragon 28, Inc.2026-08-03
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Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) (K261968)Smith & Nephew, Inc.2026-07-09
Arthrex FiberButton (K260018)Arthrex, Inc.2026-06-26
Dione PEEK Screw System (K253130)ZheJiang Decans Medical Devices Co., Ltd.2026-05-27
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Anchor with Fiber Wire and Disposable Inserter (K253027)Ortobio S.A.2026-05-06
ArthroTAK Tendon Anchor Kit (K252635)ArthroTAK, LLC2026-05-01
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line (K260921)Tigon Medical2026-04-21
Arthrex FiberTak Suture Anchor (K260561)Arthrex, Inc.2026-03-20

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Ascension MCP (P000057/S013)Smith & Nephew, Inc.2025-12-31
ASCENSION MCP (P000057/S014)Smith & Nephew, Inc.2025-08-05
R3™ Delta Ceramic Acetabular System (P150030/S049)Smith & Nephew, Inc.2025-04-17
R3 DELTA CERAMIC HIP SYSTEM (P150030/S048)Smith & Nephew, Inc.2025-03-03
R3 Delta Ceramic Hip System (P150030/S045)Smith & Nephew, Inc.2025-02-28
R3™ Delta Ceramic Acetabular System (P150030/S047)Smith & Nephew, Inc.2025-02-21
R3™ Delta Ceramic Acetabular System (P150030/S046)Smith & Nephew, Inc.2025-01-16
BIRMINGHAM HIP™ RESURFACING (BHR) SYSTEM (P040033/S039)Smith & Nephew, Inc.2025-01-10