(12 days)
Not Found
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 a "plate and screw system intended for internal fracture fixation" and is indicated for the "temporary internal fixation and stabilization of osteotomies and fractures," which are therapeutic actions.
No
The device is described as a "plate and screw system intended for internal fracture fixation," which is a treatment device, not a diagnostic one.
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:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The Zimmer Periarticular Locking Plate System is a surgical implant used for the internal fixation and stabilization of bones within the body. It is a mechanical device used to hold bone fragments together during healing.
- Lack of IVD Characteristics: The provided information does not mention any testing of bodily specimens, analysis of biological markers, or any diagnostic function.
Therefore, based on the provided information, the Zimmer Periarticular Locking Plate System is a surgical implant, not an In Vitro Diagnostic device.
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.
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 .
Product codes (comma separated list FDA assigned to the subject device)
HRS
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 (laboratory) performance testing and analysis demonstrate that the device is safe and effective.
Clinical data and conclusions were not needed for this device.
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.
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
§ 888.3030 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 word "zimmer" in a bold, sans-serif font. The "z" is stylized and enclosed in a circle. The word appears to be a logo or brand name.
JAN $ 1 2005
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Noah J. Bartsch, MS
Specialist, Corporate Regulatory Affairs
Telephone: (574) 371-8552
Fax: (574) 372-4605 |
| Date: | January 18, 2005 |
| Trade Name: | Zimmer® Periarticular Locking Plates |
| Classification Name | Plate, Fixation, Bone
Screw, Fixation, Bone |
| Classification Reference: | 21 CFR § 888.3030, 3040 |
| Predicate Device: | Zimmer® Periarticular Locking Plates
manufactured by Zimmer, Inc., K042598, cleared
October 29, 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. |
1
/
Comparison to Predicate Devices:
the same intended use, operates with the same fundamental scientific technology, is manufactured from the same materials using similar processes, and is similar in design to the predicate device.
The Zimmer Periarticular Locking Plate System has
Performance Data:
The results of non-clinical (laboratory) performance testing and analysis demonstrate that the device is safe and effective.
Clinical data and conclusions were not needed for this device.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with stylized wings and body.
JAN 3 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Noah J. Bartsch, MS Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581
Re: K050121 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: HRS Dated: January 18, 2005 Received: January 19, 2005
Dear Mr. Bartsch:
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. Iisting 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. Noah J. Bartsch, MS
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) 276-0115. 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.huml.
Sincerely yours,
Mark A. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosurc
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 .
Mark A. Mckissen
Division of General, Restorative. and Neurologica. Devi
510(k) Number K050121
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
()ver-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)
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