(85 days)
Not Found
Not Found
No
The summary describes a physical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to replace a joint due to arthritis or trauma, which is a therapeutic intervention.
No
The device description clearly states its purpose is to replace part of the thumb's metacarpal, indicating it is a prosthetic implant for treatment, not diagnosis.
No
The device description clearly states it is an "implant" made of "pyrocarbon" and is intended to be "implanted into the metacarpal of the thumb," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to replace a part of the bone (proximal end of the first metacarpal) in the human body. This is a surgical implant, not a device used to examine specimens in vitro (outside the body).
- Device Description: The device is described as an "implant" made of pyrocarbon, intended to be "implanted into the metacarpal of the thumb." This further confirms its nature as a medical device for surgical intervention.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Using reagents or assays
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The device 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 (comma separated list FDA assigned to the subject device)
87 KYI, KYI
Device Description
The Nexa Orthopedics CMI implant and surgical instruments are provided in 3 sizes. The device is intended to be implanted into the metacarpal of the thumb. The device is made of pyrocarbon. No new materials are used in the development of this implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metacarpal of the thumb
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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510 (k) Summary
| Prepared: | May 4, 2006 | MAY 10 2006 |
|---|---|---|
| Applicant: | Nexa Orthopedics, Inc., | |
| 10675 Sorrento Valley Road, Suite 100 | ||
| San Diego, CA 92121 | ||
| Telephone: | 858-866-0660 | |
| Fax: | 858-866-0661 | |
| Contact: | Louise M. Focht | |
| Device Name: | Nexa carpometacarpal (CMI) implant | |
| Device Trade Name: | Nexa carpometacarpal (CMI) implant | |
| Device Classification: | Class II | |
| Reviewing Panel: | Orthopedic | |
| Regulation Number | 888.3770 | |
| Product Code: | 87 KYI | |
| Substantial Equivalence: | Documentation is provided which | |
| demonstrated the device to be substantial | ||
| equivalent to other legally marketed | ||
| devices | ||
| Registration Number: | 2030833 | |
| Owner Operator Number: | 9028319 |
Device Description:
The Nexa Orthopedics CMI implant and surgical instruments are provided in 3 sizes. The device is intended to be implanted into the metacarpal of the thumb. The device is made of pyrocarbon. No new materials are used in the development of this implant.
Indications for Use:
The device 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 with limited range of motion.
Summary:
The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three human figures, possibly representing health, family, and community.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 0 2006
Nexa Orthopedics, Inc. c/o Ms. Louise M. Focht Vice President of Research and Development 10675 Sorrento Valley Road, Suite 100 San Diego, California 92121
Re: K060386
Trade/Device Name: Nexa Carpo Metacarpal Implant (CMI) Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: Class II Product Code: KYI Dated: February 13, 2006 Received: February 14, 2006
Dear Ms. Focht:
We have reviewed your Section 510(k) premarket notification of intent to market the device w oneve to rowe 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
2
Page 2 - Ms. Louise M. Focht
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decisions over device as described in your Section 510(k)
This letter will allow you to begin marketing your device as described in your I his letter will anow you to begin marketing your as ratence of your device to a legally premarket notification. The PDA maing of backanner of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your acon 2011-01-20120. Also, please note the regulation entitled, Contact the Office of Compunation at (210) 276 Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other geleral informational and Consumer Assistance at its toll-free number (800) 638-204 or Manufacturers, internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Haberleener co
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KO60386 Device Name: Nexa Carpo Metacarpa
Indications for Use:
The device 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.
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)
Hubert Steiner MD
Division of General, Restorative, and Neurological Devices
Page 1 of .
060386 510(k) Number
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