(87 days)
No
The document describes a mechanical implant and its physical characteristics and performance testing, with no mention of AI or ML.
Yes
The device is an implantable device used to replace the proximal end of the first metacarpal for conditions like arthritis, aiming to restore stable and functional thumb movement.
No.
The device description clearly states it is an implant intended to replace a part of the thumb joint, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a physical implant made of graphite and pyrolytic carbon, intended for surgical implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Ascension® NuGrip® CMC Implant is a physical implant designed to be surgically placed within the body to replace a joint. It does not analyze biological specimens.
- Intended Use: The intended use is to replace a damaged joint, not to diagnose a condition based on laboratory analysis.
The information provided clearly describes a surgical implant, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The Ascension® NuGrip® CMC Implant is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation or bone loss which present as either a painful, unstable thumb or a thumb with limited range of motion.
Product codes
KYI
Device Description
The Ascension NuGrip CMC Implant is a single-use, uncemented one-piece implant for the basal thumb joint. It is constructed of a graphite core encased in a layer of pyrolytic carbon. The device is offered in 9 different combinations of 3 head and 4 stem sizes. The NuGrip represents incremental design modifications to the Ascension PyroHemiSphere, including an extended proximal spherical head, a collar at the head base, modified stem geometry, and additional implant sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
basal thumb joint, first metacarpal
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)
Non-Clinical Performance Data:
In order to support substantial equivalence of the NuGrip implants to the predicate devices, the following non-clinical testing and analysis was conducted:
- CMC Joint Biomechanics Review .
- . Static Compression-Bending Testing
- Basal Tumb Implant Endurance Testing .
- . System Verification Report/Strength Analysis
- . PyroCarbon Wear Characteristics Analysis
Clinical Performance Data:
No clinical performance data were needed to support substantial equivalence of the design modifications.
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
§ 888.3770 Wrist joint carpal trapezium polymer prosthesis.
(a)
Identification. A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.(b)
Classification. Class II.
0
NOV - 4 2011
Image /page/0/Picture/2 description: The image shows the logo for Ascension Orthopedics. The logo features a black triangle on the left side, with a curved white line at the bottom. The text "Ascension Orthopedics" is written in black letters to the right of the triangle.
ASCENSION ORTHOPEDICS, INC 8700 Cameron Road AUSTIN, TEXAS 78754
Summary of Safety and Effectiveness
Sponsor:
Contact Person:
Date:
Trade Name:
Common Name:
Product Code:
Classification:
Panel:
Predicate Device:
Device Description:
Intended Use:
Ascension Orthopedics, Inc. 8700 Cameron Road Austin, TX 78754-3832
Bradley W. Strasser Regulatory Affairs Specialist 512-836-5001 ext. 1541
05 August 2011
Ascension® NuGrip® CMC Implant
Carpometacarpal (CMC) Implant
KYI - Prosthesis, Wrist, Carpal Trapezium
21 CFR §888.3770 - Wrist joint carpal trapezium polymer prosthesis
Orthopedic
Ascension® PyroHemiSphere® (PHS); K041451, cleared 25 August 2004; manufactured by Ascension Orthopedics, Inc.
Ascension® Saddle® PyroCarbon CMC; K061451, cleared 11 August 2006; manufactured by Ascension Orthopedics, Inc.
The Ascension NuGrip CMC Implant is a single-use, uncemented one-piece implant for the basal thumb joint. It is constructed of a graphite core encased in a layer of pyrolytic carbon. The device is offered in 9 different combinations of 3 head and 4 stem sizes. The NuGrip represents incremental design modifications to the Ascension PyroHemiSphere, including an extended proximal spherical head, a collar at the head base, modified stem geometry, and additional implant sizes.
The Ascension NuGrip CMC Implant is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis,
Confidential Page 13 of 149
1
Basis of Substantial Equivalence:
Non-Clinical Performance Data:
osteoarthritis, or post fracture deformation or bone loss which present as either a painful, unstable thumb or a thumb with limited range of motion.
The Ascension NuGrip CMC Implant is manufactured using identical materials and processes as the Ascension PyroHemiSphere CMC implant. The design modifications represented in the NuGrip do not raise new issues of safety or effectiveness, as shown by performance testing and analysis. The NuGrip indications for use and intended function remain unchanged from the predicate PyroHemiSphere.
In order to support substantial equivalence of the NuGrip implants to the predicate devices, the following non-clinical testing and analysis was conducted:
- CMC Joint Biomechanics Review .
- . Static Compression-Bending Testing
- Basal Thumb Implant Endurance Testing .
- . System Verification Report/Strength Analysis
- . PyroCarbon Wear Characteristics Analysis
Clinical Performance Data:
No clinical performance data were needed to support substantial equivalence of the design modifications.
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing the body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
NOV - 4 2011
Ascension Orthopedics, Inc. % Mr. Bradley W. Strasser Regulatory Affairs Specialist 8700 Cameron Road Austin, Texas 78754
Re: K112278
Trade/Device Name: Ascension NuGrip CMC Implant Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: II Product Code: KYI Dated: August 5, 2011 Received: August 9, 2011
Dear Mr. Strasser:
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. Iisting 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
3
Page 2 - Mr. Bradley W. Strasser
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutfiDA/CentersOffices/CDRH/CDRHOffices/ucm1.15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
Erine Keith
ForMark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _K1122278
Device Name:
Ascension® NuGrip® CMC Implant
Indications for Use:
The Ascension® NuGrip® CMC Implant is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation or bone loss which present as either a painful, unstable thumb or a thumb with limited range of motion.
X Prescription Use (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)
Qpcurrence of CDRH, Office of Device Evaluation (ODE)
El Keith
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112278 Confidential
Page 12 of 149