FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Arthrosurface WristMotion Total Wrist Arthroplasty System
K Number: K200718
·
Decision Oct 15, 2020
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
16
Applicant Total
26
Review Days
210
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Basic Information
- Device Name
- Arthrosurface WristMotion Total Wrist Arthroplasty System
- K Number
- K200718
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3800
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthrosurface, Inc.
- Date Received
- March 19, 2020
- Decision Date
- October 15, 2020
- Product Code
- JWJ
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWJ), ordered by most recent decision date.
Total Wrist Arthroplasty System (TWA)
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Freedom Wrist Arthroplasty System
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KinematX Total Wrist Arthroplasty System
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INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
FDA 510(k)
FDA Class 2
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MAESTRO WRIST FRACTURE IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Arthrosurface, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K203375 | OVOMotion Reverse Shoulder Arthroplasty System | Jun 24, 2021 | Substantially Equivalent |
| K190261 | BOSS Toe Fixation System | Aug 14, 2019 | Substantially Equivalent |
| K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty System | Jun 14, 2018 | Substantially Equivalent |
| K173964 | OVOMotion Shoulder Arthroplasty System | Apr 18, 2018 | Substantially Equivalent |
| K172383 | Arthrosurface Bone Screws | Dec 22, 2017 | Substantially Equivalent |
| K170440 | KISSloc Suture System | May 3, 2017 | Substantially Equivalent |
| K170350 | ToeMATE® Hammertoe Correction System | Mar 3, 2017 | Substantially Equivalent |
| K162391 | AlignMATE Lapidus Arthrodesis System | Feb 21, 2017 | Substantially Equivalent |
| K161539 | Arthrosurface Bone Screws | Jun 30, 2016 | Substantially Equivalent |
| K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Apr 11, 2016 | Substantially Equivalent |