(74 days)
Not Found
No
The summary describes a mechanical external fixator and makes no mention of AI or ML.
Yes
The device is described as assisting in the healing of fractures and providing stability, which are therapeutic functions.
No
Explanation: The device is described as an "external fixator" that provides "stability and distraction for pins inserted through the skin into the bone" to assist in healing. This indicates a therapeutic or assistive function, not a diagnostic one. Diagnostic devices are used to identify or determine the nature of a disease or condition.
No
The device description explicitly states it is an "external fixator" and an "external frame," indicating it is a physical hardware device used to stabilize bones.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Description: The BioSymMetRic Proximal Interphalangeal Joint Fixator is an external fixator that is applied to the outside of the body to stabilize bones. It does not involve the analysis of bodily specimens.
- Intended Use: The intended uses are related to the mechanical stabilization and healing of bone fractures and dislocations, not the diagnosis of a condition through laboratory testing.
Therefore, this device falls under the category of a surgical or orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
-
- Complex fracture-dislocations of the proximal Interphalangeal joint.
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- Unstable PIP dislocations
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- Post-traumatic contracture of the PIP joint
Product codes (comma separated list FDA assigned to the subject device)
87JDW, 87HTY, 87KTT
Device Description
The BioSymMetRic Proximal Interphalangeal Joint Fixator is an external fixator to assist in the healing of fractures or other bone cutting procedures of the fingers. The device is an external frame to provide stability and distraction for pins inserted through the skin into the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal interphalangeal joint, fingers
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.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for Biomet Inc. The logo is in black and white and features the company name in a bold, sans-serif font. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller font.
APR 1 4 1998
980390
Summary of Safety and Effectiveness
Proprietary Name: BioSymMetRic™ Proximal Interphalangeal Joint Fixator
Classification Name and Product Code: Similar devices are classified in many The following classifications have been used for different categories. similar products:
-
Smooth or threaded metallic bone fixation fastener (888.3040), 87JDW or 87HTY
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Appliance, fixationnail/blade/plate combination, multiple component (888.3030), 87KTT
Device Classification: Class II
Intended Use:
-
- Complex fracture-dislocations of the proximal Interphalangeal joint.
-
- Unstable PIP dislocations
-
- Post-traumatic contracture of the PIP joint
Device Description: The BioSymMetRic Proximal Interphalangeal Joint Fixator is an external fixator to assist in the healing of fractures or other bone cutting procedures of the fingers. The device is an external frame to provide stability and distraction for pins inserted through the skin into the bone.
Potential Risks: The potential risks associated with this device include but are not limited to:
Infection Hematoma Pin loosening Nerve Damage Blood vessel damage Deformity of the joint Fracture of device Metal sensitivity
Bone Fracture Soft tissue imbalance Excessive Wear Disassociation of the components
Substantial Equivalent Device: Compass® Proximal Interphalangeal (PIP) Hinge from Smith & Nephew Richards cleared through 510(k) K970713.
MAHING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580
.
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@biomet.com
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
APR 1 4 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia Sandborn Beres ·Director, Requlatory Affairs Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
K980370 Re: BioSymMetRic™ Proximal Interphalangeal Joint Fixator Regulatory Class: II Product Code: KTT January 27, 1998 Dated: January 30, 1998 Received:
Dear Ms. Beres:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Patricia Sandborn Beres
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debtired in your cial equivalence of your device to a legally rinaing or eabsours device results in a classification for your markets produced or mits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Stephen Rhodes
elia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: BioSymMetRic™ Proximal Interphalangeal Joint Fixator
Indications For Use:
-
- Complex fracture-dislocations of the proximal Interphalangeal joint.
-
- Unstable PIP dislocations
-
- Post-traumatic contracture of the PIP joint
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) X
OR
Over-The-Counter Use_
Stathm Plurdes
(Optional Format 1-2-96)
(Division Sign Division of General Restorativ 510(k) Number