(21 days)
No
The summary describes a mechanical plate and screw system for fracture fixation and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an "internal fixation and stabilization" system for fractures and osteotomies, which directly treats a medical condition.
No
The device is described as a "plate and screw system intended for internal fracture fixation," which is a therapeutic rather than a diagnostic function. The "Intended Use / Indications for Use" section also lists various types of fractures that the system is indicated for temporary internal fixation and stabilization, further supporting its therapeutic purpose.
No
The device description clearly states it is a "plate and screw system," which are physical hardware components used for internal fracture fixation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "temporary internal fixation and stabilization of osteotomies and fractures". This describes a surgical implant used within the body to treat bone issues.
- Device Description: The description details a "plate and screw system intended for internal fracture fixation". This further reinforces its role as a surgical implant.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The information provided describes a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Universal Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including;
- Comminuted fractures .
- Supracondylar fractures .
- Extra-articular fractures .
- Fractures in osteopenic bone .
- Nonunions .
- Malunions .
Product codes
HRS
Device Description
The Zimmer Universal Locking System is a plate and screw system intended for internal fracture fixation. The plate selection consists of dual compression, reconstruction, tubular, straight "T", straight "L" and oblique "L" configurations. Plates accommodate either standard or locking screws via figure-8 shaped holes.
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
Non-Clinical Performance and Conclusions:
The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the Zimmer logo. The logo consists of a large, bold letter 'Z' enclosed in a circle, followed by the word 'zimmer' in a smaller, sans-serif font. The 'Z' in the circle is the most prominent element, drawing the eye with its size and enclosure.
Summary of Safety and Effectiveness
K063303
NOV 2 2 2006
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Anthony Francalancia
Senior Associate, Regulatory Affairs
Telephone: (574) 372-4570
Fax: (574) 372-4605 |
| Date: | October 31, 2006 |
| Trade Name: | Zimmer® Universal Locking System |
| Common Name: | 2.7mm Locking Plate System |
| Classification Name
and Reference: | Plate, Fixation, Bone (21 CFR § 888.3030)
Screw, Fixation, Bone (21 CFR § 888.3040) |
| Predicate Device: | Zimmer® Universal Locking System 3.5mm Plates
and Screws, manufactured by Zimmer, Inc.,
K060710, cleared April 26, 2006. |
| Device Description: | The Zimmer Universal Locking System is a plate
and screw system intended for internal fracture
fixation. The plate selection consists of dual
compression, reconstruction, tubular, straight "T",
straight "L" and oblique "L" configurations. Plates
accommodate either standard or locking screws via
figure-8 shaped holes. |
| Intended Use: | The Universal Locking System is indicated for
temporary internal fixation and stabilization of
osteotomies and fractures, including comminuted
fractures, supracondylar fractures, extra-articular
fractures, fractures in osteopenic bone, nonunions
and malunions. |
| Comparison to Predicate Device: | The Zimmer Universal Locking System 2.7mm
plates and screws have the same intended use,
similar performance characteristics, are |
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Image /page/1/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" enclosed in a circle, followed by the word "zimmer" in a bold, sans-serif font. The logo is black and white.
manufactured from the same materials and are similar in design to the predicate device.
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles facing to the right. The profiles are rendered in black and are connected by flowing lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer. Inc. % Mr. Anthony Francalancia Senior Associate, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581
NOV 2 2 2006
Re: K063303
Trade/Device Name: Universal Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Codc: HRS Dated: October 31, 2006 Received: November 1, 2006
Dear Mr. Francalancia:
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. Anthony Francalancia
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) 276-0210 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 vours.
Barbara Buechner
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Universal Locking System, 2.7mm Locking Plates and Screws
Zimmer Universal Locking Plate System
Indications for Use:
The Universal Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including;
- Comminuted fractures .
- Supracondylar fractures .
- Extra-articular fractures .
- Fractures in osteopenic bone .
- Nonunions .
- Malunions .
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Starbare bruchn
(Division Sign-Cif) Division of General, Restorative, and Neurological Devices
510(k) Number K063303
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