(77 days)
Not Found
No
The summary describes a mechanical bone fixation system with no mention of software, algorithms, or any technology related to AI or ML.
No
This device is an internal fixation system for fracture fixation and correction of deformity, which is a structural support device rather than one that treats a disease or condition.
No
The device is described as an internal fixation system used for repairing bone fractures and deformities, not for diagnosing conditions.
No
The device description explicitly states it is comprised of physical components (plates and screws) made of Ti-6Al-4V, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis." This describes a surgical implant used to fix bones within the body.
- Device Description: The device is described as an "internal fixation system comprised of Ti-6Al-4V and consisting of various-sized plates and screws." This further confirms it's a physical implant for surgical use.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease. IVDs are typically used for diagnosis, monitoring, or screening based on analysis of biological samples.
Therefore, the Biomet Variable Locking Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Biomet Variable Locking Plate System is used for adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Biomet Variable Locking Plate System is an internal fixation system comprised of Ti-6Al-4V and consisting of various-sized plates and screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic, small and long bone, tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones
Indicated Patient Age Range
adult or pediatric patients
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 Testing: Engineering analyses comparing the Biomet Variable Locking Plate System to a predicate device were conducted to determine substantial equivalence. The results indicated that the Biomet Variable Locking Plate System was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
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
JUL 26 2007
510(k) Summary
| Preparation Date: | July 10, 2007 |
|---|---|
| Applicant/Sponsor: | Biomet Trauma (formerly known as EBI Trauma) |
| 100 Interpace Parkway | |
| Parsippany, NJ 07054 | |
| Contact Person: | Debra L. Bing |
| Director, Requlatory Affairs | |
| Biomet Trauma | |
| 973.299.9300 | |
| Proprietary Name: | Biomet Variable Locking Plate System |
| Common Name: | Metallic bone plates and screws |
| Classification Name: | Single/multiple component metallic bone fixation appliances and accessories, |
| 21 CFR $888.3030 | |
| Product Code(s): | HRS, HWC |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
| EBI Anterior Cervical Plate System (Cyprus) | K060379 | EBI, L.P. |
|---|---|---|
| IQL Stainless Steel Bone Plates and Screws | K020221 | Biomet Orthopedics, Inc |
Device Description: The Biomet Variable Locking Plate System is an internal fixation system comprised of Ti-6Al-4V and consisting of various-sized plates and screws.
Indications for Use: The Biomet Variable Locking Plate System is used for adult or pediatric patients as indicated for pelvic, small and long bone fraction and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.
Summary of Technologies: The technological characteristics of the Biomet Variable Locking Plate System are the same as, or similar to, the predicate devices.
Non-Clinical Testing: Engineering analyses comparing the Biomet Variable Locking Plate System to a predicate device were conducted to determine substantial equivalence. The results indicated that the Biomet Variable Locking Plate System was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc. unless otherwise noted.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 2007
Biomet Trauma % Ms. Susan Alexander Senior Regulatory Specialist P.O. Box 587 Warsaw. Indiana 46581-0587
Re: K071325
Trade/Device Name: Biomet Variable Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: May 9, 2007 Received: May 10, 2007
Dear Ms. Alexander:
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.
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. Susan Alexander
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Harbare Muchimp
for
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
5:10(k) Number (if known): K07 | 325
Device Name: Biomet Variable Locking Plate System
Indications For Use:
The Biomet Variable Locking Plate System is used for adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aarbai bonem
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K021324
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