FDA.reportPublic FDA data

510(k) K233592

Device
BioPoly Radial Head Implant
Applicant
BioPoly, LLC
510(k) number
K233592
Product code
KWI
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-13
Date received
2023-11-08
Regulation
888.3170
Classification name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Herb Schwartz
Address
7136 Gettysburg Pike Fort Wayne IN US 46804 46804

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KWI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231188ALIGN Radial Head SystemSkeletal Dynamics, Inc.2023-09-28
K213563DePuy Synthes Radial Head Replacement SystemDePuy Synthes2022-03-18
K212872Avenger Radial Head SystemIn2bones USA, LLC2021-12-17
K192754Avenger Radial Head SystemIn2bones USA, LLC2020-01-07
K183618Revolution Radial HeadIgnite Orthopedics, Inc.2019-05-17
K172688Align Radial Head SystemSkeletal Dynamics, LLC2017-12-22
K132735AXIA RADIAL HEAD SYSTEMImds (Innovative MEdical Device Systems) - Leis ME2014-01-07
K131845ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOCAcumed, LLC2013-09-30
K112030SYNTHES RADIAL HEAD PROSTHESIS SYSTEMSynthes USA, LLC2012-06-19
K092721ALIGN RADIAL HEAD SYSTEMSkeletal Dynamics, LLC2010-08-03
K062898SBI LATERAL RHEAD IMPLANTSmall Bone Innovations, Inc.2006-11-13
K060731EVOLVE MODULAR RADIAL HEADWrightmedicaltechnologyinc2006-04-19
K051385EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICEBiomet, Inc.2005-08-05
K041858ACUMED ANATOMIC RADIAL HEAD SYSTEMAcumed, LLC2004-10-05
K040611MODULAR RADIAL HEAD REPLACEMENT DEVICEBiomet, Inc.2004-06-04