ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS

K140508 · Zimmer, Inc. · HRS · Aug 14, 2014 · Orthopedic

Device Facts

• Record ID: K140508
• Device Name: ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS
• Applicant: Zimmer, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Aug 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ZPS One-Third Tubular Plates, T-Plates and Semi-Tubular plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as: comminuted fractures supracondylar fractures extra-articular fractures fractures in osteopenic bone nonunions malunions Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet. ZPS Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.

Device Story

Zimmer Plates and Screws System (ZPS) comprises non-locking, stainless steel plates and screws for temporary bone fixation. Plates feature spherical sliding slope holes to provide compression across fracture sites. Surgeons select plate shapes and sizes based on patient anatomy and injury fragment dimensions. Used in clinical settings for orthopedic trauma; devices provide mechanical stabilization to bone segments during natural healing. Benefits include fracture reduction and support for bone union. System is provided non-sterile.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including biocompatibility testing per ISO 10993-1 and mechanical performance testing (four-point bend testing and beam bending cross-sectional analysis).

Technological Characteristics

Stainless steel bone fixation plates and screws. Features spherical sliding slope plate hole design for compression. Non-sterile. Biocompatibility verified per ISO 10993-1. Mechanical performance validated via four-point bend testing and cross-sectional analysis.

Indications for Use

Indicated for patients requiring temporary internal fixation and stabilization of osteotomies and fractures, including comminuted, supracondylar, and extra-articular fractures, fractures in osteopenic bone, nonunions, and malunions. Smaller plates are indicated for small bones and fragments of the hands and feet.

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

• Sterile Zimmer Plates and Screws System (ZPS) - Screws only (K112885)
• TMP Microplating System (K921458)
• Zimmer Universal Locking System 3.5mm Locking Plates and Screws (K060710)
• Zimmer Universal Locking System 2.7mm Locking Plates and Screws (K063303)

Submission Summary (Full Text)

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August 14, 2014

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

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

Re: K140508 Trade/Device Name: Zimmer® Plates and Screws System (ZPS) - Non-Sterile Plates and Screws 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, HTN Dated: June 19, 2014 Received: June 20, 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, listing 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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Stephen H. McKelvey

device-related adverse events) (21 CFR 803); 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. 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" (21 CFR 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,

Mark N. Melkerson -S

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

Enclosure

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## Indications for Use

510(k) Number (if known)

#### K140508

# Device Name

Zimmer Plates and Screws System (ZPS) - Non-Sterile Plates and Screws

#### Indications for Use (Describe)

ZPS One-Third Tubular Plates, T-Plates and Semi-Tubular plates are indication and stabilization of osteotomies and fractures, such as:

- comminuted fractures
- supracondylar fractures
- extra-articular fractures
- · fractures in osteopenic bone
- nonunions
- malunions

Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet.

ZPS Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.

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

|× Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

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

Expiration Date: January 31, 2017

See PRA Statement on last page.

Pg. 1/1

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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: | August 12, 2014 |
| Trade Name: | Zimmer® Plates and Screws System (ZPS) – Non-Sterile<br>Plates and Screws |
| Common Name: | Temporary Internal Fixation Devices |
| Classification Names<br>and References: | Single/multiple component metallic bone fixation<br>appliances and accessories (21 CFR 888.3030) and Smooth<br>or threaded metallic bone fixation fastener (21 CFR<br>888.3040) |
| Classification Panel: | Orthopedics/87, Product codes HRS, HWC, HTN |
| Predicate Devices: | Sterile Zimmer Plates and Screws System (ZPS) - Screws<br>only (K112885), TMP Microplating System (K921458),<br>Zimmer Universal Locking System 3.5mm Locking Plates<br>and Screws (K060710) and Zimmer Universal Locking<br>System 2.7mm Locking Plates and Screws (K063303). |
| Purpose and Device Description: | The Zimmer Plates and Screws System (ZPS) is a non-<br>locking, stainless steel plate and screw system. Plate<br>shapes vary to address varying patient bone sizes and injury<br>fragment sizes. Plates incorporate a spherical sliding slope<br>plate hole design to achieve the compression required to<br>treat bone fractures. The plates are used with a variety of<br>screws for temporary fixation to the bone. |
| Intended Use: | ZPS One-Third Tubular Plates, T-Plates and Semi-Tubular<br>plates are indicated for temporary internal fixation and<br>stabilization of osteotomies and fractures, such as: |
| | |
| • comminuted fractures<br>• supracondylar fractures<br>• extra-articular fractures<br>• fractures in osteopenic bone<br>• nonunions<br>• malunions<br>Smaller-sized ZPS plates are used for small bones and<br>small fragments of the hands and feet.<br>ZPS Screws are temporary internal fixation devices<br>designed to stabilize fractures during the normal healing<br>process. | |
| Comparison to Predicate Device: | The ZPS Plates/Screws are similar in intended use, basic<br>shape, compatible screw diameters, materials and<br>performance characteristics to the predicate devices. The<br>subject devices are provided non-sterile. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions:<br>• Biocompatibility - Biocompatibility testing on the<br>plate and screw material was conducted per ISO 10993-<br>1 and Good Laboratory Practices (21 CFR § 58). All<br>testing passed.<br>• Performance Testing - The four point bend testing<br>and/or the beam bending cross sectional analysis<br>conducted on both the subject non-sterile ZPS plates<br>and their respective predicate devices demonstrated<br>that, in all cases, the subject ZPS plates were superior in<br>strength.<br>Because the non-sterile ZPS screws are identical to the<br>sterile ZPS screws cleared under K112885 and because<br>the sterilization status for these metal devices does not<br>affect the performance testing, no additional testing<br>beyond the data included in K112885 was required.<br>Clinical Performance and Conclusions:<br>Clinical data and conclusions were not needed for these<br>devices. |

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