(69 days)
Not Found
No
The device description and intended use are for a mechanical plate and screw system for fracture fixation, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is used for temporary internal fixation and stabilization of osteotomies and fractures, which describes a surgical aid or an implant, not a therapeutic device.
No
Explanation: This device is a periarticular locking plate system used for internal fracture fixation and stabilization, not for diagnosing medical conditions. Its intended use is to treat fractures, not to identify them.
No
The device description clearly states it is a "plate and screw system intended for internal fracture fixation," which are physical hardware components.
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 to physically stabilize bone, not a test performed on samples taken from the body to diagnose a condition.
- 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: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
This device is a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The Zimmer Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Zimmer Periarticular Locking Plate System is a plate and screw system intended for internal fracture fixation. The low-profile periarticular locking plate is anatomically contoured and has threaded holes which accept locking screws to create a stable, fixed angle construct.
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 analysis demonstrate that the device is safe and effective.
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.
Zimmer ECT® Internal Fracture Fixation System, Preamendment Device, K040593
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.
Not Found
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
§ 888.3040 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 contains the word "zimmer" in a bold, sans-serif font. To the left of the word is a large, stylized letter "Z" enclosed in a circle. The "Z" is also in a bold font and appears to be the first letter of the word "zimmer."
JUL 7 - 2005
K051098 p 1/2
Traditional 510(k) Premarket Notification
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Laura D. Williams, RAC
Manager, Corporate Regulatory Affairs
Telephone: (574) 372-4523
Fax: (574) 372-4605 |
| Date: | April 29, 2005 |
| Trade Name: | Zimmer® Periarticular Locking Plate System |
| Classification Name: | Plate, Fixation, Bone
Screw, Fixation, Bone |
| Classification Reference: | 21 CFR § 888.3030,3040 |
| Predicate Device: | Zimmer ECT® Internal Fracture Fixation System,
Preamendment Device |
| | Zimmer Periarticular Locking Plate System,
K040593, cleared April 12, 2004 |
| Device Description: | The Zimmer Periarticular Locking Plate System is a
plate and screw system intended for internal
fracture fixation. The low-profile periarticular
locking plate is anatomically contoured and has
threaded holes which accept locking screws to
create a stable, fixed angle construct. |
| Intended Use: | The Zimmer Periarticular Locking Plate System is
indicated for temporary internal fixation and
stabilization of osteotomies and fractures, including
comminuted fractures, supracondylar fractures,
intra-articular and extra-articular condylar fractures,
fractures in osteopenic bone, nonunions, and
malunions. |
| Comparison to Predicate Device: | The Zimmer Periarticular Locking Plate System has
the same intended use, has similar performance
characteristics, is manufactured from similar |
1
Image /page/1/Picture/0 description: The image contains the word "zimmer" with a stylized "Z" in a circle to the left of the word. The "Z" is bold and black, while the word "zimmer" is in a smaller, sans-serif font. The overall impression is of a logo or brand mark.
materials using similar processes, and is similar in design to the predicate devices.
Performance Data:
The results of non-clinical analysis demonstrate that the device is safe and effective.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three lines extending from its head, resembling a flag.
JUL 7 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laura D. Williams, RAC Manager, Corporate Regulatory Affairs Zimmer Incorporated P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K051098 Trade/Device Name: Zimmer® Periarticular 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: HWC Dated: April 29, 2005 Received: May 2, 2005
Dear Ms. Williams:
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 - Ms. Laura D. Williams, RAC
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/industry/support/index.html.
Sincerely yours,
Hypt Clurke
m C. Provost, Ph.D. Acting 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® Periarticular Locking Plate System
Indications for Use:
The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:
- Comminuted fractures .
- . Supracondylar fractures
- Intra-articular and extra-articular condylar 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)
0017
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (DDE)
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| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K051088 |