TOTAL COMPRESSION PLATING (TCP) SYSTEM

K151442 · Wrightmedicaltechnologyinc · HRS · Sep 4, 2015 · Orthopedic

Device Facts

• Record ID: K151442
• Device Name: TOTAL COMPRESSION PLATING (TCP) SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HRS · Orthopedic
• Decision Date: Sep 4, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TCP System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. Specific examples include: Mid / Hindfoot Fusions - LisFranc Arthrodesis and/or Stabilization - 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions - Intercuneiform Fusions - Navicular-Cuneiform (NC) Fusion - Talo-Navicular (TN) Fusion - Calcaneo-Cuboid (CC) Fusion - Medial Column Fusion First metatarsal osteotomies for hallux valgus correction including: - Opening base wedge osteotomy - Closing base wedge osteotomy - Crescentic osteotomy - Proximal Chevron osteotomy - Distal Chevron osteotomy (Austin) First metatarsal fracture fixation Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion) Arthrodesis of the first metatarsophalangeal joint (MTP) including: - Primary MTP Fusion due to hallux ridgidus and/or hallux valgus - Revision MTP Fusion - Revision of failed first MTP Arthroplasty implant Flatfoot Osteotomies - Lateral Column Lengthening (Evans Osteotomy) - Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)

Device Story

Total Compression Plating (TCP) System consists of titanium bone plates; used for internal fixation of small bone fragments in foot surgery. Plates feature scalloped designs for contouring or non-scalloped designs for increased strength; available in straight, right, and left configurations. Operated by orthopedic surgeons in clinical/OR settings to stabilize fractures, perform joint fusions, or reconstruct small bones. Device provides mechanical support to bone segments during healing; aids in achieving anatomical alignment and fusion. No electronic or software components.

Clinical Evidence

No clinical data provided; substantial equivalence based on identical design to predicate device and previously submitted mechanical testing.

Technological Characteristics

Titanium bone fixation plates; various shapes/sizes including scalloped and non-scalloped configurations; straight, left, and right orientations. Mechanical fixation device; no energy source, software, or connectivity.

Indications for Use

Indicated for stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the feet in patients requiring orthopedic surgical intervention.

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

• TOTAL COMPRESSION PLATING (TCP) SYSTEM (K143025)
• ORTHOLOC® 3Di Midfoot/Flatfoot System (K121651)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol featuring three overlapping human profiles facing to the right, creating a sense of depth and unity.

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

Wright Medical Technology, Incorporated Ms. Val Myles Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117

September 4, 2015

Re: K151442 Trade/Device Name: TOTAL COMPRESSION PLATING (TCP) 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 Dated: June 22, 2015 Received: June 24, 2015

Dear Ms. Myles:

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 - Ms. Val Myles

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.

Sincerelv vours.

# 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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

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

## Indications for Use

510(k) Number (if known)

#### Device Name

TOTAL COMPRESSION PLATING (TCP) SYSTEM

## Indications for Use (Describe)

The TCP System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the feet. Specific examples include:

#### Mid / Hindfoot Fusions

- LisFranc Arthrodesis and/or Stabilization
- · 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
- · Intercuneiform Fusions
- Navicular-Cuneiform (NC) Fusion
- Talo-Navicular (TN) Fusion
- · Calcaneo-Cuboid (CC) Fusion
- Medial Column Fusion

First metatarsal osteotomies for hallux valgus correction including:

- · Opening base wedge osteotomy
- · Closing base wedge osteotomy
- · Crescentic osteotomy
- Proximal Chevron osteotomy
- · Distal Chevron osteotomy (Austin)

First metatarsal fracture fixation

Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)

Arthrodesis of the first metatarsophalangeal joint (MTP) including:

- · Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
- · Revision MTP Fusion
- · Revision of failed first MTP Arthroplasty implant

#### Flatfoot Osteotomies

- · Lateral Column Lengthening (Evans Osteotomy)
- · Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)

## 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)

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Image /page/3/Picture/0 description: The image shows the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, on the left side. To the right of the trapezoids is the word "WRIGHT" in red, and below that is the phrase "FOCUSED EXCELLENCE" in gray.

Headquarters Wright Medical Technology, Inc.

1023 Cherry Road Memphis, TN 38117

901 867 9971 vmt.com

## 510(K) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the TOTAL COMPRESSION PLATING SYSTEM.

| (a)(1). Submitted By: | Wright Medical Technology, Inc.<br>1023 Cherry Road<br>Memphis, TN 38117 |
|------------------------------------|---------------------------------------------------------------------------------------------------------|
| Date: | May 26, 2015 |
| Contact Person: | Val Myles<br>Regulatory Affairs Specialist<br>Office - [phone]<br>Fax - [phone] |
| (a)(2). Proprietary Name: | TOTAL COMPRESSION PLATING (TCP) SYSTEM |
| Common Name: | Plate, Fixation, Bone |
| Classification Name and Reference: | 21 CFR 888.3030 - Class II |
| Device Product Code, Device Panel: | HRS - Orthopedic |
| (a)(3). Predicate Device: | K143025: TOTAL COMPRESSION PLATING<br>(TCP) SYSTEM<br>K121651: ORTHOLOC® 3Di<br>Midfoot/Flatfoot System |

## (a)(4). Device Description

The TOTAL COMPRESSION PLATING SYSTEM is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. Most of the plates are scalloped in shape to allow easier bending to fit the contour of the bone. There are also nonscalloped plates to provide greater strength. The plates include straight, right, and left configurations.

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## (a)(5). INTENDED USE

The TCP System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. Specific examples include:

Mid / Hindfoot Fusions

- LisFranc Arthrodesis and/or Stabilization
- 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
- Intercuneiform Fusions
- Navicular-Cuneiform (NC) Fusion
- Talo-Navicular (TN) Fusion
- Calcaneo-Cuboid (CC) Fusion ●
- Medial Column Fusion

First metatarsal osteotomies for hallux valgus correction including:

- Opening base wedge osteotomy
- Closing base wedge osteotomy ●
- Crescentic osteotomy
- Proximal Chevron osteotomy
- . Distal Chevron osteotomy (Austin)

First metatarsal fracture fixation

Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion) Arthrodesis of the first metatarsophalangeal joint (MTP) including:

- Primary MTP Fusion due to hallux ridgidus and/or hallux valgus ●
- Revision MTP Fusion
- Revision of failed first MTP Arthroplasty implant ●

Flatfoot Osteotomies

- Lateral Column Lengthening (Evans Osteotomy) .
- Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton . Osteotomy)

## (a)(6). Technological Characteristics Comparison

The subject TOTAL COMPRESSION PLATING SYSTEM design is identical to the currently marketed TOTAL COMPRESSION PLATING SYSTEM.

## (b)(1). Substantial Equivalence - Non-Clinical Evidence

Mechanical testing and engineering analysis was previously provided in the predicate device filings. Therefore, no testing was provided for the subject device as the design is identical.

- (b)(2). Substantial Equivalence Clinical Evidence
N/A

## (b)(3). Substantial Equivalence - Conclusions

The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.