Zimmer Periarticular Plating System

K142579 · Zimmer, Inc. · HRS · Oct 22, 2014 · Orthopedic

Device Facts

• Record ID: K142579
• Device Name: Zimmer Periarticular Plating System
• Applicant: Zimmer, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Oct 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Small Distal Volar Radial Radius and Small Distal Volar Ulnar Radius plates are indicated for temporary internal fixation and stabilization of fractures and osteotomies of the volar aspect of the distal radius, including associated carpal fusions. Calcaneal plates are indicated for complex extra-articular and intra-articular fractures and osteotomies of the calcaneus. Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.

Device Story

Zimmer Periarticular Plating System consists of metallic bone plates and screws for temporary internal fixation of periarticular fractures. System facilitates interfragmentary compression and bone plating to stabilize fractures during healing. Used by orthopedic surgeons in clinical/surgical settings. Subject submission introduces non-sterile versions of previously cleared sterile screws and additional sizes of sterile plates (Distal Volar Radial Radius, Distal Volar Ulnar Radius, Lateral Calcaneal). Devices are implanted to provide mechanical support to bone segments, promoting stability during the natural bone healing process.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical performance data, including accelerated aging (10-year shelf life), biocompatibility testing per ISO 10993-1, and engineering analysis.

Technological Characteristics

Metallic bone fixation plates and screws. Biocompatibility per ISO 10993-1. Non-sterile and sterile configurations provided. No software or electronic components.

Indications for Use

Indicated for patients requiring temporary internal fixation and stabilization of distal radius fractures/osteotomies (including carpal fusions) or complex extra-articular and intra-articular calcaneal fractures/osteotomies.

Regulatory Classification

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 Plating System Screws (K111447)
• Synthes Distal Radius Plate System (K982732)
• Synthes Calcaneal Plate (K020401)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 22, 2014

Zimmer, Incorporated Mr. Stephen H. McKelvey, MA, RAC Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K142579

Trade/Device Name: Zimmer® Periarticular Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: September 12, 2014 Received: September 15, 2014

Dear Mr. McKelvey:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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### Page 2 - Mr. Stephen H. McKelvey

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K142579

Device Name

Zimmer Periarticular Plating System

#### Indications for Use (Describe)

Periarticular Plating System Small Distal Volar Radial Radius and Small Distal Volar Ulnar Radius plates are indicated for temporary internal fixation and stabilization of fractures and osteotomies of the distal radius, including associated carpal fusions.

Periarticular Plating System Calcaneal plates are indicated for complex extra-articular fractures and osteotomies of the calcaneus.

Periarticular Plating System screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## 510(k) Summary

| Sponsor: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen H. McKelvey<br>Senior Project Manager, Trauma Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | September 12, 2014 |
| Trade Name: | Zimmer® Periarticular Plating System |
| Common Name: | Periarticular Non-locking Plates and Screws |
| Classification Names<br>and References: | Single/Multiple Component Metallic Bone Fixation<br>Appliances and Accessories, 21 CFR 888.3030 (HRS);<br>Smooth or Threaded Metallic Bone Fixation Fastener 21<br>CFR 888.3040 (HWC) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Zimmer Periarticular Plating System Screws (K111447)<br>Synthes Distal Radius Plate System (K982732)<br>Synthes Calcaneal Plate (K020401) |
| Purpose and Device<br>Description: | The Zimmer Periarticular Plating System consists of<br>temporary implants (plates and screws) and<br>instrumentation for the management of periarticular bone<br>fractures through interfragmentary compression and bone<br>plating. Bone screws are provided for use with or without<br>bone plates for fractures. This submission covers non-<br>sterile versions of previously cleared sterile Zimmer<br>Periarticular Plating System screws and various sizes of<br>the following sterile plates: Distal Volar Radial Radius,<br>Distal Volar Ulnar Radius, Lateral Calcaneal. |

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| Intended Use: | Small Distal Volar Radial Radius and Small Distal Volar<br>Ulnar Radius plates are indicated for temporary internal<br>fixation and stabilization of fractures and osteotomies of<br>the volar aspect of the distal radius, including associated<br>carpal fusions. Calcaneal plates are indicated for complex<br>extra-articular and intra-articular fractures and osteotomies<br>of the calcaneus. Screws are temporary internal fixation<br>devices designed to stabilize fractures during the normal<br>healing process. |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate Device: | The Zimmer Periarticular Plating System plates and<br>screws covered by this submission are substantially<br>equivalent to the predicate devices, in that they have the<br>same intended use, function, and fundamental scientific<br>technology. The differences between the subject and<br>predicate devices do not raise new issues of safety or<br>effectiveness. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions: |
| | • Shelf Life - Accelerated aging testing conducted<br>shows that the sterile devices included in this<br>submission have a shelf life of 10 years. |
| | • Biocompatibility – Biocompatibility testing of the<br>subject devices was conducted per ISO 10993-1 and<br>Good Laboratory Practices (21 CFR 58). All testing<br>passed. |
| | • Performance Testing – Engineering analysis<br>demonstrates the devices are safe and effective and<br>substantially equivalent to the predicate devices. |
| | Conclusions: The non-clinical performance data presented<br>in this submission show the subject devices will perform<br>in a substantially equivalent manner to the predicate<br>devices. |
| | Clinical Performance and Conclusions: |
| | Clinical data and conclusions were not needed for these<br>devices to show substantial equivalence. |