(41 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 indicated for "temporary internal fixation and stabilization of osteotomies and fractures," which directly addresses a medical condition or injury.
No
The device description clearly states it is a "plate and screw system intended for internal fracture fixation." It is used to fix physical fractures, not to diagnose medical conditions.
No
The device description clearly states it is a "plate and screw system," which are hardware components.
Based on the provided information, 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 to treat bone conditions within the body.
- Device Description: The description details a "plate and screw system intended for internal fracture fixation". This further confirms its use as a surgical implant.
- 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 outside the body to analyze samples and provide diagnostic information. This device is used inside the body for structural support and fixation.
N/A
Intended Use / Indications for 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.
Product codes
HRS, HWC
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" and oblique "T" 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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 circle with a stylized "Z" inside it, followed by the word "zimmer" in lowercase letters. The "Z" is black, and the circle is white with a black outline.
Traditional 510(k) Premarket Notification
Summary of Safety and Effectiveness
: 3 ୍ୟ ନ
| 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: | March 15, 2006 |
| Trade Name: | Zimmer® Universal Locking System |
| Common Name: | 3.5mm Locking Plate System |
| Classification Name
and Reference: | Plate, Fixation, Bone (21 CFR § 888.3030)
Screw, Fixation, Bone (21 CFR § 888.3040) |
| Predicate Devices: | Zimmer® ECT® Internal Fracture Fixation system
(Pre-amendment device).
Synthes Small Fragment Dynamic Compression
Locking (DCL) System (K000684, cleared April 28,
2000). |
| 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"
and oblique "T" 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 plates have
the same intended use, similar performance |
1
Image /page/1/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle, followed by the word "zimmer" in a smaller, sans-serif font. The letter "Z" is black, and the word "zimmer" is also black.
characteristics, are manufactured from similar materials and are similar in design to the predicate devices.
Performance Data:
The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2005
Zimmer, Inc. c/o Mr. Anthony Francalancia Senor Associate, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K060710
Trade/Device Name: Zimmer Universal 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: March 15, 2006 Received: March 16, 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 max 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. Your 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
3
Page 2 - Mr. Anthony Francalancia
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nil RP Ozil
Mark N. Melkerson
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:
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)
(Division Sign-Off)
Niel R.C. Ogle for mxp
Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number K060710