FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL

K023437 · Disco-O-Tech Medical Technologies, Ltd. · HSB · Nov 14, 2002 · Orthopedic

Device Facts

• Record ID: K023437
• Device Name: FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL
• Applicant: Disco-O-Tech Medical Technologies, Ltd.
• Product Code: HSB · Orthopedic
• Decision Date: Nov 14, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Hip: - femoral head/neck fractures or non-unions; . I - aseptic necrosis of the femoral head/neck; and - osteo-, theumatoid, and post-traumatic arthritis of the hip, with mimmal acetabular involvement Femur: - ー fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures: proximal femoral fractures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures; - = use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, and revision procedures in the femur; - ー mid shaft fractures in the femur (5 cm below the surgical neck to 5 cm proximal to the distal end of the medullar canal); - comminuted shaft fractures; ー - fixation of short distal or proximal fragments - Tibia: - diaphyseal shaft fractures in the tibia: - - comminuted shaft fractures: ー - fixation of short distal or proximal fragments Humerus: - ー diaphyseal shaft fractures in the humerus: - comminuted shaft fractures: - fixation of short distal or proximal fragments -

Device Story

Intramedullary nailing system for orthopedic fracture fixation; includes nails and inflation device (nail pump/hip peg pump). Device utilizes expandable nail technology; surgeon inserts nail into medullary canal; inflation pump expands nail to achieve fixation against bone walls. Used in OR by orthopedic surgeons. Output is mechanical stabilization of bone fragments. Benefits include secure fixation of fractures and bone reconstruction. System includes accessories made of stainless steel and silicone.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Implants manufactured from 316L Stainless Steel (ASTM F 138). Accessories incorporate surgical grade Stainless Steel, Silicone, and Celeron. Designed per ASTM F 565. Mechanical expansion principle for fixation. Non-powered, manual instrumentation.

Indications for Use

Indicated for patients with hip fractures/non-unions, aseptic necrosis, or arthritis; femur fractures (shaft, proximal, pertrochanteric, intertrochanteric, subtrochanteric, comminuted, pathological), osteotomy, nonunions, malunions, tumor resection, and revision; tibial diaphyseal/comminuted/short fragment fractures; and humeral diaphyseal/comminuted/short fragment fractures.

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

• Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, K012967)
• Fixion IM Nailing System (K990717, K003212, K003215, K010901, K021324)
• Fixion IL Nailing System (K002783, K013449)
• Fixion UH Hemi-Hip System (K014072)

Submission Summary (Full Text)

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

NOV 1 4 2002

| Disc-O-Tech Medical Technologies, Ltd. |
|------------------------------------------------------------------|
| Fixion Interlocking Proximal Femur Intramedullary Nailing System |

K023437

## 510(k) Summary

# Disc-O-Tech Medical Technologies, Ltd. Fixion® Interlocking Proximal Femoral Intramedullary Nailing System; Fixion® Intramedullary Nailing System; Fixion® Interlocking Intramedullary Nailing System; Fixion™ Unipolar Modular Hemi-Hip System

### Company Name

Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St., Herzliya Israel, 46728

## Submitter's Name and Contact Person

Yael Rubin Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St., Herzliya Israel, 46728 Tel: [phone] Fax: [phone]

### Date Prepared

October 2002

## Trade/Proprietary Name

Fixion® Interlocking Proximal Femoral Intramedullary Nailing System; Fixion® Intramedullary Nailing System; Fixion Interlocking Intramedullary Nailing System; Fixion" Unipolar Modular Hemi-Hip System

### Classification Name

21 CFR & 888.3020, Class II, Intramedullary fixation rod

21 CFR § 888.3390, Class II, Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis

## Predicate Devices

- 1. Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, K012967) by Disc-O-Tech Medical Technologies, Ltd.
## Performance Standards

The following standards were used:

- 1. The Fixion PF Nail is manufactured from 316L Stainless Steel, which meets the requirements of ASTM F 138 Standard Specification for Stainless Steel Bar and Wire for Surgical Implants.
- 2. The Fixion PF Nailing System accessories incorporate surgical grade Stainless Steel, Silicone

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

K023437

and Celeron. '

- 3. The Fixion PF Nailing System is designed to meet the requirements of ASTM F 565 Standard Practice for Care and Handling of Orthopedic Implants and Instruments.
# Intended Use

Hip:

- femoral head/neck fractures or non-unions; . I
- aseptic necrosis of the femoral head/neck; and
- osteo-, theumatoid, and post-traumatic arthritis of the hip, with mimmal acetabular involvement

## Femur:

- ー fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures: proximal femoral fractures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures;
- = use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, and revision procedures in the femur;
- ー mid shaft fractures in the femur (5 cm below the surgical neck to 5 cm proximal to the distal end of the medullar canal);
- comminuted shaft fractures; ー
- fixation of short distal or proximal fragments -

## Tibia:

- diaphyseal shaft fractures in the tibia: -
- comminuted shaft fractures: ー
- fixation of short distal or proximal fragments

## Humerus:

- ー diaphyseal shaft fractures in the humerus:
- comminuted shaft fractures:
- fixation of short distal or proximal fragments -

# Substantial Equivalence

The Inflation Device (Nail Pump/Hip Peg Pump), which incorporates new materials and a slightly revised design, is still intended to operate in a manner similar to the Purnp currently used with the aforementioned Fixion Systems and all materials incorporated into it are already used in instrumentation supplied with those systems.

The Fixion Interlocking Proximal Femoral Intramedullary Nailing System is substantially equivalent to the following cleared Fixion Systems: Fixion IM Nailing System - K990717. K003212, K003215, K010901, K021324; Fixion IL Nailing System - K002783, K013449; and Fixion UH Hemi-Hip System - K014072. The modified Fixion PF Nailing System (modified

---

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

Page 3 of 3

Disc-O-Tech Medical Technologies, Ltd. Fixion Interlocking Proximal Femur Intramedullary Nailing System

K023437

Pump) has the following similarities to that which previously received 510(k) clearance;

- Have the same intended use -
- Have the same operating principles l
- The Implants and the Instrumentation Set incorporate the same design ー
- The Implants and the Instrumentation Set incorporate the same materials -
- The Implants and the Instrumentation Set have the same basic packaging and sterilization, using the same materials and processes.

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

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three parallel lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

#### Public Health Service

NOV 1 4 2002

9200 Corporate Bouleva Rockville MD 20850

Ms. Yael Rubin Director of Regulatory Affairs Disc-o-Tech Medical Technologies, Ltd. 3 Hasadnaot St. Herzliya 46728 ISRAEL

Re: K023437

Trade/Device Name: Fixion™ Interlocking Proximal Femoral Intramedullary Nailing System; Fixion™ Intramedullary Nailing System; Fixion™ Interlocking Intramedullary Nailing System; Fixion™ Unipolar Modular Hemi-Hip System

Regulation Number: 21 CFR 888.3020; 21 CFR 888.3390

Regulation Name: Intramedullary fixation rod; Hip joint (hemi-hip) metal/polymer cemented or uncemented prosthesis

Regulatory Class: Class II

Product Code: HSB, JDS, KWY Dated: October 10, 2002

Received: October 15, 2002

Dear Ms. Rubin:

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 enclosures) 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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

# Page 2 - Ms. Yael Rubin

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark N. Melkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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

## 510(k) Number (if known): K023437

Device Name: Fixion® Interlocking Proximal Femoral Intramedullary Nailing System; Fixion® Intramedullary Nailing System; Fixion® Interlocking Intramedullary Nailing System; Fixion™ Unipolar Modular Hemi-Hip System

## Indications For Use: These devices are indicated for the following:

#### Hip:

- femoral head/neck fractures or non-unions; -
- aseptic necrosis of the femoral head/neck; and -
- osteo-, rheumatoid, and post-traumatic arthritis of the hip, with minimal acetabular involvement

#### Femur:

- fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures; l proximal femoral fractures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures;
- use in osteotomy, nonunions, bone reconstruction following turnor resection, ー grafting and pathological fractures, and revision procedures in the femur;
- mid shaft fractures in the femur (5 cm below the surgical neck to 5 cm proximal to the distal end of the medullar canal);
- comminuted shaft fractures: -
- fixation of short distal or proximal fragments -

#### Tibia:

- diaphyseal shaft fractures in the tibia: -
- comminuted shaft fractures; -
- fixation of short distal or proximal fragments a

#### Humerus:

- diaphyseal shaft fractures in the humerus; -
- comminuted shaft fractures;
- fixation of short distal or proximal fragments -

### (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR | Over-the-Counter Use |
|------------------------|----|--------------------------|
| (Per 21 CFR § 801.109) | | (Optional Format 1-2-96) |

(Division Sign-Off)

Division of General, Restorative

and No Rogical Devices

| 510(k) Number | K023437 |
|---------------|---------|
|---------------|---------|