(40 days)
None
Not Found
No
The summary describes a mechanical implant and associated surgical tools, with no mention of software, algorithms, or any terms related to AI/ML.
No
The device, Pediatric Osteotomy Plates, is used for fixation of intertrochanteric osteotomies to treat deformities, which falls under the category of a surgical implant rather than an active therapeutic device that provides therapy itself.
No
The device, Pediatric Osteotomy Plates, is described as an implant used for fixation of osteotomies, not for diagnosing medical conditions. Its description focuses on materials, sizes, and surgical tools for implantation.
No
The device description explicitly states the plates are made from surgical implant grade 316LVM Stainless Steel and are affixed to bone using stainless steel bone screws, indicating a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- This device is a surgical implant (Pediatric Osteotomy Plates) used to fix bones directly within the body.
The description clearly indicates it's a physical implant made of stainless steel, used in a surgical procedure to treat bone deformities. This is the definition of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Pediatric Osteotomy Plates are indicated for fixation of intertrochanteric osteotomies for treating congenital or traumatic deformities in children.
Product codes
HRS
Device Description
Pediatric Osteotomy Plates are made from surgical implant grade 316LVM Stainless Steel conforming to the American Society for Testing and Materials ASTM) material standard ASTM F-138. The plates are affixed to bone utilizing currently marketed stainless steel bone screws. The plates are available in sizes suitable for use in infants, children, and adolescents. Special instrumentation is available including plate driver/extractors, chisels, goniometer guides, impactors, slide hammers, clamps, and guide wires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone (intertrochanteric osteotomies/femur)
Indicated Patient Age Range
infants, children, and adolescents
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Smith and Nephew Orthopaedics, Memphis, Tennessee Infant, Child, and Adolescent Osteotomy Blade Plates, Zimmer, Inc., Warsaw, Indiana Intertrochanteric Osteotomy Blade-Plates for Children, Synthes, Inc., Paoli, Pennsylvania Right Angled Plates for Intertrochanteric Femur Osteotomies in Infants, Children, and Adolescents
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 16 1299
510(K) SUMMARY
Image /page/0/Picture/3 description: The image shows the logo for Biomet Inc. The logo is in black and white and features the company name in a bold, blocky font. The letters are all capitalized, and the "T" in Biomet is stylized with three horizontal lines.
Date: October 29, 1998 CORPORATE HEA
Company: Biomet, Inc. P.O. Box 587 Airport Industrial Park Warsaw, Indiana 46581-0587
Device Name: Pediatric Osteotomy Plates Common Name: Osteotomy Plates Classification: Plate, fixation, bone (21 CFR 888.3030) class II
Device Description: Pediatric Osteotomy Plates are made from surgical implant grade 316LVM Stainless Steel conforming to the American Society for Testing and Materials ASTM) material standard ASTM F-138. The plates are affixed to bone utilizing currently marketed stainless steel bone screws. The plates are available in sizes suitable for use in infants, children, and adolescents. Special instrumentation is available including plate driver/extractors, chisels, goniometer guides, impactors, slide hammers, clamps, and guide wires.
Intended Use: Pediatric Osteotomy Plates are indicated for fixation of intertrochanteric osteotomies for treating congenital or traumatic deformities in children.
Substantially Equivalent Devices:
Smith and Nephew Orthopaedics, Memphis, Tennessee Infant, Child, and Adolescent Osteotomy Blade Plates
Zimmer, Inc., Warsaw, Indiana Intertrochanteric Osteotomy Blade-Plates for Children
Synthes, Inc., Paoli, Pennsylvania Right Angled Plates for Intertrochanteric Femur Osteotomies in Infants, Children, and Adolescents
The substantially equivalent devices are all similar in design and materials. The Biomet manufactured Pediatric Osteotomy plates do not raise any different questions regarding safety and effectiveness from the predicate devices.
Potential Adverse Effects for Metallic Internal Fixation Devices:
Nonunion or delayed healing of bone Implant breakage, bending, or migration Fracture of bone Infection Allergic reaction to foreign body MAILING ADDRESS
P.O. Box 587 Warsaw, IN 46581-0587
1
SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580
1
000025
OFFICE 219.267.6639
FAX 219.267.8137
1
E-MAIL biomet@biomet.com
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 1928
Mr. Lonnie Witham Senior Regulatory Affairs Specialist Biomet Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
K983967 Re: Pediatric Osteotomy Plates Trade Name: Regulatory Class: II Product Code: HRS Dated: October 28, 1998 November 6, 1998 Received:
Dear Mr. Witham:
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. A 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 regulation 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.
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Page 2 - Mr. Lonnie Witham
This letter will allow you to begin marketing your device as described in your 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 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 one organism on compitied, "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,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Page 1 of 1
510(k) Number: K983967
Device Name: Pediatric Osteotomy Plates
Indications For Use: Pediatric Osteotomy Plates are indicated for fixation of intertrochanteric osteotomies for treating congenital or traumatic deformities in children.
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(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)
Over-The Counter Use (Optional Format 1-2-96)
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OR
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 4983967