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

K143331 · Zimmer, Inc. · HRS · Mar 4, 2015 · Orthopedic

Device Facts

• Record ID: K143331
• Device Name: Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS
• Applicant: Zimmer, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Mar 4, 2015
• 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, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, Contourable Dual Compression Plates, Cloyerleaf and Spoon 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 ostectomies 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 non-locking stainless steel plates and screws; used for temporary internal fixation and stabilization of bone fractures and osteotomies. Plates feature spherical sliding slope holes to achieve compression. Surgeon selects plate shape based on patient bone size and injury fragment size; device applied during orthopedic surgery. System stabilizes fractures during natural healing process. Benefits include structural support for bone healing in various fracture types, including osteopenic bone.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical performance data, including biocompatibility testing per ISO 10993-1 and mechanical beam bending cross-sectional analysis comparing subject devices to predicates.

Technological Characteristics

Non-locking stainless steel plate and screw system. Features spherical sliding slope plate hole design for compression. Biocompatibility tested per ISO 10993-1. Provided non-sterile.

Indications for Use

Indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted, supracondylar, extra-articular, osteopenic bone fractures, nonunions, and malunions. Includes calcaneal fractures and small bone/fragment fixation in 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

• ZPS 2.7mm L-Plate, 3.5mm One Third Tubular Plate, 4.5mm T-Plate and 3.5 T Plate (K140508)
• ZPS 4.5mm T-Plate (K143066)
• ZPS 3.5/4.5mm Contourable Dual Compression Plates (K142836)

Submission Summary (Full Text)

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March 4. 2015

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

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

Re: K143331 Trade/Device Name: Zimmer Plates and Screws System (ZPS)-Non-sterile ZPS 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: February 6, 2015 Received: February 9, 2015

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Mr. Stephen H. McKelvey

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" (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.

# 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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See PRA Statement below.

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

## Indications for Use

510(k) Number (if known)

K143331

Device Name

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

Indications for Use (Describe)

ZPS One-Third Tubular Plates, T-Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, Contourable Dual Compression Plates, Cloyerleaf and Spoon 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 ostectomies 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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a large, stylized blue letter "Z" enclosed in a blue circle. Below the circle is the word "zimmer" in a lowercase, sans-serif blue font.

### 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: | November 19, 2014 |
| Trade Name: | Zimmer Plates and Screws System (ZPS) - Non-sterile<br>ZPS |
| 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, product<br>codes HRS and HTN) and Smooth or threaded metallic<br>bone fastener (21 CFR 888.3040, product code HWC) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | ZPS 2.7mm L-Plate, 3.5mm One Third Tubular Plate,<br>4.5mm T-Plate and 3.5 T Plate, (K140508, cleared August<br>14, 2014), ZPS 4.5mm T-Plate (K143066, cleared<br>November 28, 2014), and ZPS 3.5/4.5mm Contourable<br>Dual Compression Plates (K142836, cleared November<br>12,2014) |
| Purpose and Device Description: | The ZPS System is a non-locking, stainless steel plate and<br>screw system. Plate shapes vary to address varying patient<br>bone sizes and injury fragment sizes. Plates incorporate a<br>spherical sliding slope plate hole design to achieve the<br>compression required to treat bone fractures. The plates<br>are used with a variety of screws for temporary fixation to<br>the bone. |

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| <b>Indications for Use:</b> | ZPS One-Third Tubular Plates, T-Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, Contourable Dual Compression Plates, Cloverleaf and Spoon 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 subject ZPS Plates are similar in intended use, basic shape, compatible diameters, materials and performance characteristics to their respective predicate devices. The subject devices are provided non-sterile. |
| <b>Performance Data (Nonclinical and/or Clinical):</b> | |
| | <b>Non-Clinical Performance and Conclusions:</b> <ul><li>Biocompatibility - Biocompatibility testing on the ZPS Plate material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.</li><li>Beam bending cross sectional analyses of the ZPS Plates and their respective predicate devices, the ZPS L-Plates, T-Plates, and One-Third Tubular Plates, resulted in similar mechanical performance. The subject and predicate devices are substantially equivalent.</li></ul> |
| | <b>Clinical Performance and Conclusions:</b> <ul><li>Clinical data and conclusions were not needed for</li></ul> |

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