(70 days)
Not Found
No
The description focuses on traditional bone plates and screws, with no mention of AI/ML capabilities or related data/performance metrics.
Yes
The device is used for internal fixation of bone fractures and deformities, which is a therapeutic intervention aimed at restoring function and promoting healing.
No
The device description clearly states its purpose is for fracture fixation and stabilizing bone fragments, which are therapeutic functions, not diagnostic.
No
The device description explicitly states that the device is comprised of "Bone Plates and Screws," which are physical hardware components intended for surgical implantation. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that IQL Bone Plates and Screws are implanted into bones for fracture fixation and correction of deformities. This is an in vivo (within the living body) application, not an in vitro (outside the living body) test.
- Intended Use: The intended use is for fixing bones, which is a surgical procedure performed directly on the patient, not a laboratory test on a sample.
The information provided describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
IQL Bone Plates and Screws are 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, pelvis, acetabulum, 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
IQL Bone Plates and Screws are used for the same indications as stainless steel bone plates and screws that have been commercially available continually since the 1950s. These devices are to be implanted by insertion into bones for fixation of fractures, or the fixation of bones that have been surgically prepared (osteotomy) for correction of deformity, or arthrodesis. Bone screws are used to attach the plates to the bone and stabilize bone fragments until bone union has occurred. A wide variety of bone plates similar to those included in this submission have been in commercial distribution since prior to May 28, 1976.
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, pelvis, acetabulum, 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)
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.
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
APR 2 2 2002
Page 1 of a
Summary of Safety and Effectiveness
Applicant/Sponsor: Industrias Quirurgicas de Levante, S.L. Islas Baleares, 50 Poligono Fuente del Jarro Paterna, Valencia Spain 46988 Establishment Registration Number: 9610576
Lonnie Witham Contact Person: Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587 Fax: (219) 372-1683
Proprietary Name: IQL Basic Fragment Plate Set, IQL Basic Fragment Screw Set. IQL Small Fragment Set, IQL Mini Fragment Set
Common or Usual Name: Stainless Steel Bone Plates & Bone Screws
Classification Name: Plate, Fixation, Bone (21 CFR 888.3030) Screw. Fixation. Bone (21 CFR 888.3040)
Device Classification: Class II
Device Product Code: HRS (plates), HWC (screws)
Legally Marketed Devices to Which Substantial Equivalence Is Claimed: These devices are substantially equivalent to various stainless steel bone plates and screws sold by Biomet Inc. (OEC) prior to May 28,1976. Similar devices were included in the Kirschner (Biomet) Small Fragment Fixation System cleared under K864924 in March 1987.
Device Description: IQL Bone Plates and Screws are used for the same indications as stainless steel bone plates and screws that have been commercially available continually since the 1950s. These devices are to be implanted by insertion into bones for fixation of fractures, or the fixation of bones that have been surgically prepared (osteotomy) for correction of deformity, or arthrodesis. Bone screws are used to attach the plates to the bone and stabilize bone fragments until bone union has occurred. A wide variety of bone plates similar to those included in this submission have been in commercial distribution since prior to May 28, 1976.
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page 2 of 2
000093
Intended Use: IQL Bone Plates and Screws are 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, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.
Summary of Technology: This device utilizes standard technology that is commonly known by physicians. This technology has been used in commercially available metallic internal fixation devices prior to May 28, 1976. The stainless steel used to manufacture these inplants conforms to material standards published by the American Society for Testing and Materials ASTM F-138 and ASTM F-139.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2002
Mr. Lonnie Witham Biomet, Inc. P.O. Box 587 Warsaw, In 46581-0587
Re: K020221
Trade/Device Name: IQL Stainless Steel Bone Plates and Screws – Various Styles Regulation Number: 21 CFR 888.3030 and 888.3040
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener
Regulatory Class: Class II Product Code: HRS, HWC Dated: January 21, 2002 Received: January 22, 2002
Dear Mr. Witham:
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 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.
3
Page 2 - Mr. Lonnie Witham
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
for Mark n Mcherson
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of
STATEMENT OF INDICATIONS FOR USE
| 510(k) Number | K020221
and the first for the country of the province of the country of the county of |
| --------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Device Name: IQL Stainless Steel Bone Plates & Screws - Various Styles
Indications for Use:
IQL Bone Plates and Screws are used for adult or pediatric patients as indicated for IQL Bone Flates and OOOve are are as as a see a can fixation of bones that have been surgically prepared (ostentomy) for correction of deformity or arthrodesis. Surgically propared (ostedits) / For tibia, fibula, fibula, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.
(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)
OR
Over-The-Counter-Use __
(Optional Format 1-2-96)
for
Mach N Millere
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number __K020221