← Product Code [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS) · K042598 # PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES (K042598) _Zimmer, Inc. · HRS · Oct 29, 2004 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K042598 ## Device Facts - **Applicant:** Zimmer, Inc. - **Product Code:** [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS.md) - **Decision Date:** Oct 29, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## 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. ## Device Story Zimmer Periarticular Locking Plate System consists of low-profile, anatomically contoured metallic plates with threaded holes and locking screws. Used for internal fracture fixation and stabilization of osteotomies. Operated by surgeons in clinical settings. Locking mechanism provides stable construct for bone healing, particularly in osteopenic bone. Device supports fracture reduction and alignment during healing process. ## Clinical Evidence Bench testing only. Non-clinical laboratory performance testing demonstrated safety and effectiveness. ## Technological Characteristics Metallic bone fixation plates and screws. Low-profile, anatomically contoured design. Features threaded holes for locking screw interface. Materials and manufacturing processes are similar to predicate devices. ## Regulatory 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. ## Predicate Devices - Zimmer® Periarticular Locking Plate System ([K040593](/device/K040593.md)) - Synthes Locking Condylar Plate (LCP) System – 4.5mm LCP Condylar Plate ([K000066](/device/K000066.md)) - Zimmer® ECT® Internal Fracture Fixation System (Preamendments) - Synthes LCP System - 3.5/4.5mm LCP Metaphyseal Plate System ([K033805](/device/K033805.md)) - Zimmer® Magna-Fx® Cannulated Screw Fixation System (Preamendments) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter "Z" inside it, followed by the word "zimmer" in a bold, sans-serif font. The letter "Z" is black, and the word "zimmer" is also black. K042598 | OCT 2 9 2004 | 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: | September 22, 2004 | | | Trade Name: | Zimmer® Periarticular Locking Plates | | | Classification Name: | Plate, Fixation, Bone
Screw, Fixation, Bone | | | Classification Reference: | 21 CFR § 888.3030,3040 | | | Predicate Devices: | Zimmer® Periarticular Locking Plate System
K040593, cleared April 12, 2004 | | | | Synthes Locking Condylar Plate (LCP) System –
4.5mm LCP Condylar Plate, K000066, cleared
March 15, 2000 | | | | Zimmer® ECT® Internal Fracture Fixation System,
Preamendments Device | | | | Synthes LCP System - 3.5/4.5mm LCP
Metaphyseal Plate System, K033805, cleared
February 20, 2004 | | | | Zimmer® Magna-Fx® Cannulated Screw Fixation
System, Preamendments Device | | | 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 | | | 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 Devices: | The Zimmer Periarticular Locking Plate System has
the same intended use, has similar performance
characteristics, is manufactured from similar
materials using similar processes, and is 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. | | : {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a stylized letter "Z" inside of a circle, followed by the word "zimmer" in lowercase letters. The letter "Z" and the word "zimmer" are both in a bold, sans-serif font. {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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 2 9 2004 Mr. Noah J. Bartsch, MS Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581 Re: K042598 Trade/Device Name: Zimmer® Periarticular Locking System Regulation Number: 21 CFR 888.3030, 21 CFR 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HRS, HWC Dated: September 22, 2004 Received: September 23, 2004 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, 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 {3}------------------------------------------------ ### Page 2 - Mr. Noah J. Bartsch, MS 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 (OS) 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 vours. sincerely, yours, L. Mark X. Mellum 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 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 . L. Mark A. Mchuson Division of General, Restorative, and Neurological Devices 510(k) Number K042598 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) Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K042598](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K042598) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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