(160 days)
No
The summary describes a mechanical implant and surgical instruments, with no mention of AI/ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the partial replacement of wrist joints to alleviate pain, deformity, and limited motion caused by various conditions, which are therapeutic endpoints.
No
The device is described as an implant used for partial replacement of wrist joints, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a system consisting of a contoured articular implant, a taper post, and instruments, all made of metal alloys. This indicates a physical, hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a surgical implant designed to replace a portion of the wrist joint. It is a physical device implanted into the body.
- Intended Use: The intended use is to treat conditions affecting the wrist joint through surgical implantation, not through testing bodily samples.
The device described is a surgical implant or prosthetic device, not an IVD.
N/A
Intended Use / Indications for Use
Indicated for use as a partial replacement of wrist joint(s) disabled by pain, deformity and/or limited motion caused by:
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic ● arthritis and avascular necrosis
- Rheumatoid arthritis .
- Revision where other devices or treatments have failed ●
- Scapholunate Advanced Collapse (SLAC) and other functional deformities ●
- Trauma, including fractures of the carpal bones ●
The device is a single use implant intended to be used with bone cement.
Product codes
KWN, KWN, KWO
Device Description
The Arthrosurface HemiCAP® Wrist Hemiarthroplasty System consists of a contoured articular implant designed to articulate with the natural radius bone, a taper post and set of instruments used for implant site preparation and delivery. The resurfacing components are manufactured using implant grade cobalt-chrome alloy and will be offered in two diameters, and four articular radii. The taper post is manufactured using implant grade titanium alloy and is offered in one fixed size designed to work with all resurfacing implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist joint(s)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In support of this submission, the following non-clinical tests have been performed on the Subject Device:
- Axial Assembly / Disassembly of Articular and Fixation components o
- Resistance to Torque ●
- Static Compression
- Dynamic Fatigue
- Fretting & Corrosion ●
The results have demonstrated the safety and effectiveness of the Arthrosurface Wrist Hemiarthroplasty Implants along with substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3750 Wrist joint carpal lunate polymer prosthesis.
(a)
Identification. A wrist joint carpal lunate prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal lunate bone of the wrist.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black against a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2014
Arthrosurface, Incorporated Ms. Dawn J. Wilson Vice President, Quality & Regulatory 28 Forge Parkway Franklin, Massachusetts 02038
Re: K141920
Trade/Device Name: Wrist Hemiarthroplasty System Regulation Number: 21 CFR 888.3750 Regulation Name: Wrist joint carpal lunate polymer prosthesis Regulatory Class: Class II Product Code: KWN, KWN, KWO Dated: November 21, 2014 Received: November 24, 2014
Dear Ms. Wilson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 – Ms. Dawn J. Wilson
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 4 Indications for Use Statement
510(k) Number (if known): K141920
Device Name: Wrist Hemiarthroplasty System
Indications for Use:
Indicated for use as a partial replacement of wrist joint(s) disabled by pain, deformity and/or limited motion caused by:
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic ● arthritis and avascular necrosis
- Rheumatoid arthritis .
- Revision where other devices or treatments have failed ●
- Scapholunate Advanced Collapse (SLAC) and other functional deformities ●
- Trauma, including fractures of the carpal bones ●
The device is a single use implant intended to be used with bone cement.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Section 5 510(k) Summary
| 510(k) Owner: | Arthrosurface, Inc.
28 Forge Parkway
Franklin, MA02038
Tel: 508.520.3003
Fax: 508.528.4604 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dawn Wilson
VP, Quality & Regulatory |
| Date of Preparation: | November 21st, 2014 |
| Trade Name: | Wrist Hemiarthroplasty System |
| Common Name: | Partial Wrist Joint |
| Device: | Prosthesis, Wrist |
| Classification Regulation: | Prosthesis, Wrist Carpal Lunate (21 CFR 888.3750)
and/or Prosthesis, Wrist Carpal Scaphoid (21 CFR 888.3760) |
| | The Arthrosurface Wrist Hemiarthroplasty System
requires removal of both the lunate and the scaphoid
bones therefore it does not clearly fit one
classification. |
| Device Class: | Class II |
| Review Panel: | Orthopedic |
| Product Code: | KWN, KWO |
Device Intended Use
The Arthrosurface Wrist Hemiarthroplasty System is indicated for use as a partial replacement of wrist joint(s) disabled by pain, deformity and/or limited motion caused by:
- . Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis.
- . Rheumatoid arthritis.
- Revision where other devices or treatments have failed. ●
- Scapholunate Advanced Collapse (SLAC) and other functional deformities. ●
4
- Trauma, including fractures of the carpal bones. ●
The device is a single use implant intended to be used with bone cement.
Device Description
The Arthrosurface HemiCAP® Wrist Hemiarthroplasty System consists of a contoured articular implant designed to articulate with the natural radius bone, a taper post and set of instruments used for implant site preparation and delivery. The resurfacing components are manufactured using implant grade cobalt-chrome alloy and will be offered in two diameters, and four articular radii. The taper post is manufactured using implant grade titanium alloy and is offered in one fixed size designed to work with all resurfacing implants.
Substantial Equivalency:
Arthrosurface demonstrated that for the purposes of FDA's requlation of medical devices, the Wrist Hemiarthroplasty System is substantially equivalent in indications and design principles to the following predicate device, which has been previously cleared by the FDA:
Biomet Maestro Carpal Hemi-Arthroplasty (K050028, Cleared on 07/07/08)
The fundamental scientific technology of the proposed device has not changed relative to the predicate device.
- Hemiarthroplasty of the wrist joint
- Same indications for use ●
- Similar device designs ●
- Same implant materials ●
In support of this submission, the following non-clinical tests have been performed on the Subject Device:
- Axial Assembly / Disassembly of Articular and Fixation components o
- Resistance to Torque ●
- Static Compression
- Dynamic Fatigue
- Fretting & Corrosion ●
The results have demonstrated the safety and effectiveness of the Arthrosurface Wrist Hemiarthroplasty Implants along with substantial equivalence to the predicate device.