Zimmer Natural Nail System

K172114 · Zimmer, Inc. · HSB · Aug 10, 2017 · Orthopedic

Device Facts

• Record ID: K172114
• Device Name: Zimmer Natural Nail System
• Applicant: Zimmer, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Aug 10, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the Greater Trochanter and Piriformis Fossa Antegrade Femoral nails in the femur include: - Compound and simple shaft fractures - Proximal, metaphyseal and distal shaft fractures - Segmental fractures - Comminuted fractures - Fractures involving osteopenic and osteoporotic bone - Pathological fractures - Fractures with bone loss - Pseudoarthrosis, non-union, mal-union and delayed union - Periprosthetic fractures - Surgically created defects such as osteotomies - Intertrochanteric and subtrochanteric fractures. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the retrograde femoral nails in the femur include: - Compound and simple shaft fractures - Proximal, metaphyseal, and distal shaft fractures - Segmental fractures - Closed supracondylar fractures - Severely comminuted supracondylar fractures with articular involvement - Fractures involving femoral condyles - Comminuted fractures - Fractures involving osteopenic and osteoporotic bone - Pathological fractures - Fractures with bone loss - Pseudoarthrosis, non-union, and mal-union - Periprosthetic fractures - Poly trauma patients

Device Story

Zimmer Natural Nail System is a family of intramedullary nails for temporary femoral fracture fixation and stabilization. System includes nails of various lengths/diameters, secured by 6.0mm fixed angle screws passing through proximal/distal nail holes. Components include nail caps, cortical washers, and cortical nuts. Used by orthopedic surgeons in clinical settings to stabilize femoral fractures. Device provides mechanical support to bone segments during healing. Output is the physical stabilization of the fracture site, enabling patient recovery.

Clinical Evidence

No clinical data. Bench testing performed including screw three-point bend test, proximal nail fatigue construct test, distal nail fatigue construct test, and non-pyrogenicity testing.

Technological Characteristics

Intramedullary fixation rod system. Components made of Ti-6Al-4V alloy; cortical nut contains UHMWPE. Fixed angle screw design. Mechanical fixation via intramedullary placement. Sterilization method same as predicate.

Indications for Use

Indicated for temporary fracture fixation and stabilization of the femur in patients with compound/simple shaft fractures, proximal/metaphyseal/distal shaft fractures, segmental fractures, comminuted fractures, osteopenic/osteoporotic bone fractures, pathological fractures, bone loss, pseudoarthrosis, non-union, mal-union, delayed union, periprosthetic fractures, surgically created defects (osteotomies), intertrochanteric/subtrochanteric fractures, closed supracondylar fractures, severely comminuted supracondylar fractures with articular involvement, femoral condyle fractures, and poly trauma.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails (K083497)
• Zimmer Natural System Retrograde Femoral Nails (K101622)

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

Zimmer Inc. Dhaval Saraiya Regulatory Affairs Senior Specialist 345 East Main Street Warsaw, Indiana 46580

Re: K172114

Trade/Device Name: Zimmer Natural Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: July 10, 2017 Received: July 13, 2017

Dear Mr. Saraiya:

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-

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August 10, 2017

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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/ResourcesforYou/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,

### 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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2301V932 ИАМИН ОНА НТЈАЭН ЗО ТИЭМТЯАЧЭО Food and Drug Administration

udications for Use

### See PRA Statement below Expiration Date: January 31, 2017 Form Approved: OMBBIolo. 0900-0120

### 510(k) Number (if know

77777717

Device Name Zimmer Natural Nail System

## Indications for Use (Describe)

ANTEGRADE FEMORAL NAILS:

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FOR CONTINUOUS MONITORING AND
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- Proximal, metaphyseal and distal shaft fractures Componing and simple shaft fractures
- Segmental fractures
- Comminuted fractures
- Fractures involving osteopenic and osteoporotic bon
- Pathological fractures
- Fractures with bone loss
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- Periprosthetic fractures
- Surgically created defects such as osteotomies
- Interfrochanteric and subtrochanteric fracture

## RETROGRADE FEMORAL NAILS:

on one in formations but unders in the firsten from the first list. Inches of t Innications for use of the retroges ade femore in the femur include:

- Compound and simple shaft fractures
- Proximal, metaphyseal and distal shaft fractures
- Segmental fractures
- Closed supracondylar fractures
- Severy commininted supracondy lar fractures with articular involvement
- Fractures involving femoral condyles
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- Comminuted fractures
- Fractures involving osteopenic and osteoporotic bon
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- Pathological fractures
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- Pseudoarthrosis, non-union, and mal-unio
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- Periprosthefic fractures
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- Poly frauna patients
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Image /page/4/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, the word "zimmer" is written in lowercase blue letters, using a modern sans-serif font.

### 510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Zimmer Natural Nail (ZNN) – 6.0mm Fixed Angle Screws 510(k) premarket notification.

| Sponsor: | Zimmer, Inc.<br>345 E Main St<br>Warsaw, IN 46580<br>Establishment Registration Number: 1822565 | | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Dhaval Saraiya<br>Regulatory Affairs Sr. Specialist<br>Telephone: [phone])<br>Fax: [phone]) | | |
| Date: | August 9, 2017 | | |
| Subject Device: | Trade Name: Zimmer Natural Nail System<br>Common Name: Intramedullary Fixation Road<br>Classification Name:<br>• HSB- Rod, Fixation, Intramedullary and Accessories<br>(21 CFR 888.3020) | | |
| Predicate Device(s): | K083497 | Zimmer Natural Nail System Piriformis<br>Fossa and Greater<br>Trochanter Antegrade<br>Femoral Nails | Zimmer Inc. |
| | K101622 | Zimmer Natural<br>System Retrograde<br>Femoral Nails | Zimmer Inc. |
| Purpose and Device<br>Description: | The intent of this premarket notification is to provide new<br>mechanical testing data for the Zimmer Natural Nail<br>System - 6.0mm Fixed Angle Screws which is different<br>than the performance specifications submitted in the<br>original premarket notifications mentioned above. The<br>reason for two predicate devices being identified in this<br>submission is because these screws are used with both<br>Zimmer Natural Nail System - Piriformis Fossa and Greater | | |

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Trochanter Antegrade Femoral Nails and Retrograde Femoral Nails and different sizes were cleared in both submissions. Since these screws are used for various nails in the same product family, we think that this still qualifies as a special 510(k) submission.

The Zimmer Natural Nail System is a family of temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. The nails are available in a variety of lengths and diameters to meet the assorted anatomical needs. Each of the intramedullary nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps, cortical washers and cortical nuts are available for use with the system. All components are made of Ti-6Al-4V alloy. The cortical nut also contains UHMWPE.

### Intended Use and Indications for Use:

### ANTEGRADE FEMORAL NAILS:

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the Greater Trochanter and Piriformis Fossa Antegrade Femoral nails in the femur include:

- Compound and simple shaft fractures
- · Proximal, metaphyseal and distal shaft fractures
- Segmental fractures
- · Comminuted fractures
- · Fractures involving osteopenic and osteoporotic bone
- Pathological fractures
- Fractures with bone loss
- · Pseudoarthrosis, non-union, mal-union and delayed union
- Periprosthetic fractures
- · Surgically created defects such as osteotomies
- · Intertrochanteric and subtrochanteric fractures

### RETROGRADE FEMORAL NAILS:

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the retrograde femoral nails in the femur include:

- · Compound and simple shaft fractures
- Proximal, metaphyseal, and distal shaft fractures
- Segmental fractures
- Closed supracondylar fractures

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- Severely comminuted supracondylar fractures with articular involvement
- · Fractures involving femoral condyles
- · Comminuted fractures
- · Fractures involving osteopenic and osteoporotic bone
- Pathological fractures
- Fractures with bone loss
- · Pseudoarthrosis, non-union, and mal-union
- · Periprosthetic fractures
- Poly trauma patients

### Summary of Technological Characteristics:

The rationale for substantial equivalence is based on consideration of the following characteristics:

- Intended Use: Same as the predicate device
- Indications for Use: Same as the predicate device
- Materials: Same as the predicate device ●
- Design Features: Same as the predicate device ●
- . Sterilization: Same as the predicate device

### Summary of Performance Data (Nonclinical and/or Clinical)

### ● Non-Clinical Tests:

- Screw Three Point Bend Test O
- Proximal Nail Fatigue Construct Test o
- Distal Nail Fatigue Construct Test O
- Testing has been performed to establish product o non-pyrogenicity
- Clinical Tests: ●
- o N/A

### Substantial Equivalence Conclusion

The information provided within this premarket notification demonstrates that the Zimmer Natural Nail System Screws are substantially equivalent to the predicate devices.