Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers

K143066 · Zimmer, Inc. · HRS · Nov 28, 2014 · Orthopedic

Device Facts

• Record ID: K143066
• Device Name: Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers
• Applicant: Zimmer, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Nov 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, T-Plates, L-Buttress Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, and Contourable Dual Compression 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 Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneus. ZPS and Forte Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.

Device Story

Zimmer Plates and Screws System (ZPS) comprises nonlocking stainless steel plates, screws, and washers; used for temporary internal fixation and stabilization of bone fractures and osteotomies. Plates feature spherical sliding slope holes to provide compression; washers distribute load to prevent screw head breakthrough in bone cortex. System addresses varying bone and fragment sizes. Used by orthopedic surgeons in clinical settings to stabilize fractures during healing. Benefits include mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing per ISO 10993-1 and GLP (21 CFR 58) passed. Mechanical performance established via beam bending cross-sectional analysis comparing subject plates to predicates (K140508, K921458), demonstrating similar mechanical properties.

Technological Characteristics

Nonlocking stainless steel plates, screws, and washers. Plate holes utilize spherical sliding slope design for compression. Biocompatibility per ISO 10993-1. Mechanical properties validated via beam bending analysis.

Indications for Use

Indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted, supracondylar, extra-articular, and osteopenic bone fractures, as well as nonunions and malunions. Smaller plates for small bones/fragments of hands and feet; calcaneal plates for 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 Plates and Screws System (ZPS) (K140508)
• TMP Micro-plating System (Anspach/Techmedica, K921458)

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

November 28, 2014

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

Re: K143066

Trade/Device Name: Zimmer® Plates and Screws System (ZPS) - Non-sterile ZPS Plate Line Extensions, Sterile/Non-sterile ZPS Screws and Washers Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS, HTN, HWC Dated: October 23, 2014 Received: October 31, 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

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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K143066

#### Device Name

Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS Plate Line Exterile ZPS Screws and Washers

#### Indications for Use (Describe)

ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, T-Plates, Cobra Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, and Contourable Dual Compression 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 Calcaneal plates are indicated for temporary internal fixation of osteotomies and fractures of the calcaneus. ZPS and Forte 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)

#### 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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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: | October 23, 2014 |
| Trade Name: | Zimmer® Plates and Screws System (ZPS) – Non-Sterile<br>ZPS Plate Line Extensions, Sterile/Non-Sterile ZPS<br>Screws and Washers |
| 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, HRS and<br>HTN) and Smooth or threaded metallic bone fixation<br>fastener (21 CFR 888.3040, HWC) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Zimmer Plates and Screws System (ZPS) (K140508,<br>cleared August 14, 2014)<br>TMP Micro-plating System (Anspach/Techmedica,<br>K921458, cleared July 17, 1992) |
| Purpose and Device Description: | The Zimmer Plates and Screws System (ZPS) is a<br>nonlocking, stainless steel plate and screw system. Plate<br>shapes vary to address varying patient bone sizes and<br>injury fragment sizes. Plates incorporate a spherical<br>sliding slope plate hole design to achieve the compression<br>required to treat bone fractures. The plates are used with a<br>variety of screws for temporary fixation to the bone. The<br>ZPS Washers are intended to prevent a screw head from<br>breaking through the cortex of the bone by distributing the |

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| <b>Intended Use:</b> | forces/load over a larger area when used for non-plate, bone fragment, and fracture fixation. |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, T-Plates, L-Buttress Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, and Contourable Dual Compression Plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as: |
| | <ul><li>comminuted fractures</li><li>supracondylar fractures</li><li>extra-articular fractures</li><li>fractures in osteopenic bone</li><li>nonunions</li><li>malunions</li></ul> |
| | Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet. |
| | ZPS Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneus. ZPS and Forte Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process. |
| <b>Comparison to Predicate Device:</b> | The ZPS Plates, Screws and Washers are similar in intended use, basic shape, compatible diameters, materials and performance characteristics to the predicate devices. |
| <b>Performance Data (Nonclinical and/or Clinical):</b> | <b>Non-Clinical Performance and Conclusions:</b> |
| | <ul><li>Biocompatibility - Biocompatibility testing on the plate, screw, and washer material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.</li><li>Beam bending cross sectional analysis of the ZPS Plates and the predicate devices, Zimmer Plate and Screw System (K140508) and the TMP Micro-Plating System (K921458), resulted in similar mechanical properties. The subject and predicate devices are substantially equivalent.</li><li>The subject screws are substantially equivalent to those cleared in K140508 and are a line extension to screw types already cleared in K140508.</li></ul> |

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- The subject washers are substantially equivalent to and . are a line extension to the washer cleared in K140508.
Clinical Performance and Conclusions:

- Clinical data and conclusions were not needed for . these devices.