Atlas FDA

KWI

34 FDA 510(k) clearances · Product code

126 daysmedian time to decision
276 days90th percentile
34clearances measured

FDA profile

Official device name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3170
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 44 · 2022: 44 · 2023: 77 · 2024: 124 · 2025: 121 · 2026: 23
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Arthrex Radial Head Replacement System (K260624)Arthrex, Inc.2026-07-30
BioPoly Radial Head Implant (K233592)BioPoly, LLC2024-03-13
ALIGN Radial Head System (K231188)Skeletal Dynamics, Inc.2023-09-28
DePuy Synthes Radial Head Replacement System (K213563)DePuy Synthes2022-03-18
Avenger Radial Head System (K212872)In2bones USA, LLC2021-12-17
Avenger Radial Head System (K192754)In2bones USA, LLC2020-01-07
Revolution Radial Head (K183618)Ignite Orthopedics, Inc.2019-05-17
Align Radial Head System (K172688)Skeletal Dynamics, LLC2017-12-22
AXIA RADIAL HEAD SYSTEM (K132735)Imds (Innovative MEdical Device Systems) - Leis ME2014-01-07
ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC (K131845)Acumed, LLC2013-09-30
SYNTHES RADIAL HEAD PROSTHESIS SYSTEM (K112030)Synthes USA, LLC2012-06-19
ALIGN RADIAL HEAD SYSTEM (K092721)Skeletal Dynamics, LLC2010-08-03
SBI LATERAL RHEAD IMPLANT (K062898)Small Bone Innovations, Inc.2006-11-13
EVOLVE MODULAR RADIAL HEAD (K060731)Wrightmedicaltechnologyinc2006-04-19
EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE (K051385)Biomet, Inc.2005-08-05
ACUMED ANATOMIC RADIAL HEAD SYSTEM (K041858)Acumed, LLC2004-10-05
MODULAR RADIAL HEAD REPLACEMENT DEVICE (K040611)Biomet, Inc.2004-06-04
KATALYST RADIAL HEAD IMPLANT (K032806)Kinetikos Medical, Inc.2004-04-16
ASCENSION MODULAR RADIAL HEAD (K032686)Ascension Orthopedics, Inc.2003-10-22
KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT (K030237)Kapp Surgical Instrument, Inc.2003-08-29
EVOLVE CERAMIC RADIAL HEAD IMPLANT (K030384)Wrightmedicaltechnologyinc2003-08-12
MODIFICATION TO RADIAL HEAD IMPLANT (K023604)Avanta Orthopaedics, Inc.2002-11-27
LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE (K012551)Biomet, Inc.2002-01-30
RADIAL HEAD IMPLANT (K011819)Avanta Orthopaedics, Inc.2001-06-19
RADIAL HEAD IMPLANT (K002644)Avanta Orthopaedics, Inc.2000-11-20
TORNIER BIPOLAR RADIAL HEAD PROSTHESIS (K994041)Tornier, Inc.2000-08-31
HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS (K001385)Howmedica Osteonics Corp.2000-07-27
ERS RADIAL HEAD REPLACEMENT (K000658)DePuy Orthopaedics, Inc.2000-05-11
RADIAL HEAD PROSTHESIS (K992220)Smith & Nephew, Inc.2000-02-25
MODULAR RADIAL HEAD (K991915)Wrightmedicaltechnologyinc1999-09-03
IMPLEX RADIAL HEAD REPLACEMENT SYSTEM (K984290)Implex Corp.1999-06-01
RADIAL HEAD IMPLANT (K982288)Avanta Orthopaedics, Inc.1998-09-08
METALLIC RADIAL HEAD IMPLANTS (K944507)Wrightmedicaltechnologyinc1995-07-13
CL UNIVERSAL HIP DEVICE (K885146)Lima Intl. Corp.1989-04-24

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Every clearance here is in the API, with alerts when new ones post.