Product code KWD— Orthopedic
Accu-Joint Hemi Implant
- Classification name
- Prosthesis, Toe, Hemi-, Phalangeal
- Device class
- Class 2
- Regulation
- 21 CFR 888.3730
- Advisory panel
- Orthopedic
- Total cleared
- 46
- First cleared
- Most recent
Market context for product code KWD
FDA has cleared devices under product code KWD between 1979 and 2026, filed by 27 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2017
- 2016
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
Top applicants under product code KWD
Adverse events under product code KWD
product code KWD- Injury
- 164
- Total
- 164
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code KWD
- K250074 — HYALEX® MTP Hemiarthroplasty Implant
- K240268 — Accu-Joint Hemi Implant
- K221220 — Montross Extremity Medical Hemi Implant System
- K222964 — BioPoly Lesser Toe Hemiarthroplasty Implant
- K201393 — restor3d MTP Implant
- K203634 — BioPoly Great Toe Hemiarthroplasty Implant
- K200951 — Accu-Joint Hemi Implant
- K190261 — BOSS Toe Fixation System
- K190543 — Cannulated Hemi Implant
- K161279 — Life Spine Metatarsal Hemi Implant
- K152454 — HemiCAP MTP Resurfacing Hemi-Arthroplasty System
- K131377 — HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT
- K131187 — LESSER METATARSAL HEAD IMPLANT SYSTEM
- K121973 — BIOPRO HEMI-EDGE TOE SYSTEM
- K113752 — METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET
- K120029 — HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET
- K102401 — HEMI IMPLANT; MINI HEMI IMPLANT
- K092047 — ASCENSION METAL GREAT TOE SYSTEM
- K090127 — METATARSAL DECOMPRESSION IMPLANT, MODEL 100
- K083469 — METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000
- K081876 — OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING
- K073635 — SBI SR MTP TOE IMPLANT
- K073065 — OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM
- K072922 — 3S HEMI TOE
- K071243 — METAL HEMI IMPLANT
- K070052 — MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION
- K063370 — CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY
- K063058 — ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS
- K062908 — ORTHROPRO HEMI TOE
- K062040 — SBI TRIHEDRON MTP HEMI GT
- K060536 — OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM
- K060560 — ASCENSION PYROSPHERE CMC/TMT
- K041595 — TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870
- K023684 — CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365
- K031859 — CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT
- K030319 — ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
- K023770 — K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)
- K021063 — GREAT TOE IMPLANT
- K014164 — GREAT TOE IMPLANT SYSTEM
- K003629 — MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03
- K971047 — FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT
- K911378 — TOWNLEY GREAT TOE JOINT
- K875249 — SUTTER PHALANGEAL CAP
- K864492 — SWANSON TITANIUM GREAT TOE IMPLANT
- K861983 — SUTTER LESSER METATARSAL CAP
- K781870 — IMPLANT, H.P. CONDYLAR
Data sourced from openFDA. This site is unofficial and independent of the FDA.