Tyber Medical Wedge System

K150394 · Tyber Medical, LLC · PLF · Jul 28, 2015 · Orthopedic

Device Facts

• Record ID: K150394
• Device Name: Tyber Medical Wedge System
• Applicant: Tyber Medical, LLC
• Product Code: PLF · Orthopedic
• Decision Date: Jul 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PEEK System Indications The Tyber Medical Wedge System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot such as: - Cotton and Evans Wedges - Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus - Opening wedge of Medial Cuneiform of Cotton osteotomies - Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) - Midfoot Wedges - Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus - Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus) The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine TyPEEK System Indications The Tyber Medical TyPEEK Wedge System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot such as: - Cotton and Evans Wedges - Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus - Opening wedge of Medial Cuneiform of Cotton osteotomies - Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) - Midfoot Wedges - Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus - Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus) The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine

Device Story

Tyber Medical Wedge System consists of bone wedges for internal fixation in ankle/foot surgery. Implants feature open architecture for bone graft packing; superior/inferior surfaces include teeth for engagement. Available in PEEK-Optima or PEEK with plasma-sprayed commercially pure titanium coating. Used by orthopedic surgeons in clinical settings to stabilize osteotomies or fusions; requires ancillary fixation. Device provides structural support during bone healing; benefits patient by maintaining alignment and facilitating fusion/fixation.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical mechanical testing including static/dynamic compression, compression-shear, torsion, and expulsion testing per ASTM F2077. Coating characterization included static shear (ASTM F1044), static tension (ASTM F1147), and abrasion (ASTM F1978).

Technological Characteristics

Materials: PEEK-Optima, commercially pure titanium coating. Design: Open architecture wedge with surface teeth. Mechanical testing: ASTM F2077 (compression, torsion). Coating testing: ASTM F1044 (shear), ASTM F1147 (tension), ASTM F1978 (abrasion).

Indications for Use

Indicated for internal bone fixation for fractures, fusions, or osteotomies in the ankle and foot, including Cotton, Evans, and midfoot wedges (e.g., Hallux Valgus, medial cuneiform, lateral column lengthening, TMT/Lapidus arthrodesis). Intended for use with ancillary fixation. Not for use in the spine.

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

• WRIGHT MEDICAL; Biofoam – K140531

Reference Devices

• IBALANCE MEDICAL; AKR FX Medical Opening Wedge Tibial System – K092381
• TYBER MEDICAL; Tyber Medical Interbody System – K130573
• LIFE SPINE; Pro-Link Wedge System – K141905

Submission Summary (Full Text)

{0}------------------------------------------------

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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized image of three human profiles facing to the right, stacked one behind the other.

July 28, 2015

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

Tyber Medical LLC Mr. Jeff Tyber CEO and President 89 Headquarters Plaza North, #1464 Morristown, New Jersey 07960

Re: K150394 Trade/Device Name: Tyber Medical Wedge System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: PLF, HRS, HWC Dated: June 19, 2015 Received: June 22, 2015

Dear Mr. Tyber:

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

{1}------------------------------------------------

Page 2 – Mr. Jeff Tyber

(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/ResourcesforYou/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

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known) K150394

Device Name Tyber Medical Wedge System

Indications for Use (Describe) PEEK System Indications

The Tyber Medical PEEK Wedge System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot such as:

- · Cotton and Evans Wedges
- o Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus o Opening wedge of Medial Cuneiform of Cotton osteotomies
- o Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- Midfoot Wedges
- o Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- o Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)

The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine

#### TyPEEK System Indications

The Tyber Medical TyPEEK Wedge System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot such as:

- · Cotton and Evans Wedges
- o Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- o Opening wedge of Medial Cuneiform of Cotton osteotomies
- o Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- · Midfoot Wedges
- o Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- o Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)

The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

{3}------------------------------------------------

# 510(k) Summary of Safety and Effectiveness:

## TYBER MEDICAL Wedge System

| Submitter by: | Tyber Medical LLC<br>89 Headquarters Plaza North, #1464<br>Morristown, New Jersey 07960 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Mark Schenk<br>Director of Quality and Regulatory<br>Phone: [phone] Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | July 17, 2015 |
| Common Names | Bone Wedge<br>Osteotomy Bone Wedge |
| Trade Name | Tyber Medical Wedge System |
| Classification Name<br>and Number | Single/multiple component metallic bone fixation appliances and accessories<br>(21 CFR 888.3030)<br>Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) |
| Product Code | PLF, HRS and HWC |
| Primary Predicates<br>Devices | 1. WRIGHT MEDICAL; Biofoam – K140531 |
| Reference Devices | 1. IBALANCE MEDICAL; AKR FX Medical Opening Wedge<br>Tibial System – K092381<br>2. TYBER MEDICAL; Tyber Medical Interbody System –<br>K130573<br>3. LIFE SPINE; Pro-Link Wedge System – K141905 |
| Device Description | The Tyber Medical Wedge System, manufactured from PEEK-Optima®,<br>consist of implants available in various foot prints, heights and indication<br>configurations with an open architecture to accept packing of bone graft<br>materials. The exterior of the device has "teeth" or other generally sharp<br>engagement members on the superior and inferior surfaces. The device come<br>in a PEEK or PEEK with a plasma-sprayed commercially pure titanium<br>coating on the superior and inferior surfaces. |
| Intended Use/<br>Indications for use | PEEK System Indications<br>The Tyber Medical Wedge System is intended to be used for internal bone<br>fixation for bone fractures or osteotomies in the ankle and foot such as:<br>• Cotton and Evans Wedges |
| Performance Data<br>(Clinical) | Clinical data and conclusions were not needed for this device. |
| Statement of | The Tyber Medical Wedge System and its predicate devices have the same |
| Technological<br>Comparison | indications for use; same design; are made of similar materials, same application, and have the same anatomic mechanical properties. |

{4}------------------------------------------------

- Opening wedge osteotomies of the bones of the foot including O osteotomies for Hallux Valgus
- O Opening wedge of Medial Cuneiform of Cotton osteotomies
- Lateral Column Lengthening (Evans Lengthening Osteotomy O or Calcaneal Z Osteotomy)
- Midfoot Wedges ●
- Opening wedge osteotomies of the bones of the foot including O osteotomies for Hallux Valgus
- Nonunion of arthrodesis of the Midfoot including o Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)

The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine

#### TyPEEK System Indications

The Tyber Medical Wedge System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot such as:

- Cotton and Evans Wedges
- Opening wedge osteotomies of the bones of the foot including o osteotomies for Hallux Valgus
- Opening wedge of Medial Cuneiform of Cotton osteotomies O
- Lateral Column Lengthening (Evans Lengthening Osteotomy O or Calcaneal Z Osteotomy)
- Midfoot Wedges ●
- O Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- O Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)

The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine

Performance Data Non-clinical mechanical testing was performed consisting of Static (Non-Clinical) Compression, Dynamic Compression, Static Compression-Shear, Static Torsion, Dynamic Torsion per ASTM F2077. Additionally, Expulsion testing was performed. The coating characterization tests include Static Shear per ASTM F 1044, Static Tension per ASTM F 1147, and Abrasion per ASTM F 1978. All data indicates the device is substantial equivalence to the predicate svstems

{5}------------------------------------------------

| Conclusion | The Tyber Medical Wedge System is substantially equivalent to its predicate devices. This conclusion is based upon indications for use, materials, design test data and principles of operation. |
|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|