(29 days)
Not Found
Not Found
No
The summary describes a mechanical orthopedic implant (plates and crimps) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device is an orthopedic implant (plate and crimps) used for stability in trochanteric fractures and osteotomies, which is a supportive and corrective function, not a therapeutic one that actively heals or treats a disease.
No
Explanation: The device description indicates it is a surgical implant (plates and crimps for trochanteric osteotomies and fractures), not a tool for diagnosing medical conditions.
No
The device description explicitly states that the device consists of physical components (crimps and trochanteric plates) made of metallic materials (stainless steel or Co-Cr-Mo). This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures involving the trochanteric region of the femur (extended trochanteric osteotomies, trochanteric fractures, trochanteric osteotomies). This is a surgical implant used in vivo (within the body).
- Device Description: The device is described as plates and crimps made of metallic materials (stainless steel and Co-Cr-Mo) designed for surgical fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly an in vivo surgical implant.
N/A
Intended Use / Indications for Use
Lateral Trochanteric Plates: extended trochanteric osteotomies, trochanteric fractures, trochanteric osteotomies.
Product codes
HRS
Device Description
The Modified BMP™ Trochanteric Plates consist of crimps and trochanteric plates. The crimps are made of either 316LVM stainless steel or Co-Cr-Mo. The CoCr crimps are to be used in conjunction with CoCr wire and stainless steel crimps are to be used in conjunction with stainless steel wire. The trochanteric plates are made of CoCrMo and are available in two different lengths. The shorter plate is available in both right and left configurations while the longer plate will be straight and have a different contour in the trochanter region than the shorter plates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
NOV 1 6 1999
SUMMARY OF SAFETY AND EFFECTIVENESS
Sponsor: Biomet, Inc.
Manufacturer: Biomet Manufacturing, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587
Proprietary Name: Modified BMP™ Trochanteric Plates
Common or Usual Name: Single/Multiple Component Metallic Bone Fixation Appliances
Classification Name: Bone, Fixation, Plate 888.3030
Device Classification: Class II
- Device Description: The Modified BMP™ Trochanteric Plates consist of crimps and trochanteric plates. The crimps are made of either 316LVM stainless steel or Co-Cr-Mo. The CoCr crimps are to be used in conjunction with CoCr wire and stainless steel crimps are to be used in conjunction with stainless steel wire.
The trochanteric plates are made of CoCrMo and are available in two different lengths. The shorter plate is available in both right and left configurations while the longer plate will be straight and have a different contour in the trochanter region than the shorter plates.
Indications For Use:
Lateral Trochanteric Plates: extended trochanteric osteotomies, trochanteric fractures, trochanteric osteotomies.
Potential Risks:
-
- Nonunion or delayed union which may lead to breakage of implant.
-
- Bending or fracture of the implant.
-
- Loosening or migration of the implant.
-
- Metal sensitivity, or allergic reaction to a foreign body.
-
- Limb shortening due to compression of the fracture or bone resorption.
-
- Decrease in bone density due to stress shielding.
-
- Pain, discomfort, or abnormal sensation due to the presence of the device.
-
- Nerve damage due to surgical trauma.
-
- Necrosis of bone.
-
- Postoperative bone fracture and pain.
-
- Inadequate healing.
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles in a row, with flowing lines beneath them, resembling waves or fabric.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 1999
Mr. Fred McClure Requlatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
Re: K993510 Modified BMP™ Trochanteric Plates Trade Name: Regulatory Class: II Product Code: HRS Dated: October 15, 1999 Received: October 18, 1999
Dear Mr. McClure:
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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉੱ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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.
2
Page 2 - Mr. Fred McClure
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 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,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510 (k) Number (if known) : _ k 9935 10
Modified BMP™ Trochanteric Plates Device Name:
Indications For Use:
Lateral Trochanteric Plates: extended trochanteric osteotomies, trochanteric fractures, trochanteric osteotomies.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
(Per 21 CFR 801.109)
Dcolleto
(Division Sign-Off) (Division of General Restorative Devices & 993SLO
510(k) Number