ENSPLINTRX BONE FIXATION SYSTEM

K071809 · Sonoma Orthopedic Products, Inc. · HRS · Feb 21, 2008 · Orthopedic

Device Facts

• Record ID: K071809
• Device Name: ENSPLINTRX BONE FIXATION SYSTEM
• Applicant: Sonoma Orthopedic Products, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Feb 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ENSPLINTRx™ Distal Radius System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable: - Joint destruction and/or subluxation visible on x-ray; . - Osteotomy and repair of distal radius malunion with or without bone graft; - Non-displaced fractures in which the physician and patient opt for rigid stability - Transverse fractures of the distal radius with or without comminution (e.g. AO classifications A2 and A3) - Transverse fractures of the distal radius with an extension into the joint without comminution (e.g. AO classification C1); - Failed fracture fixation with or without bone graft for the types of fractures above; - The above types of fractures (i.e. AO classifications non-displaced transverse, A2, A3, and C1) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.

Device Story

The ENSPLINTRx Distal Radius System is a flexible intramedullary implant designed for the fixation of distal radius fractures. It is manufactured from stainless steel. The device is intended for use by surgeons in a clinical or hospital setting to provide rigid stability for fractures where closed reduction is insufficient. By providing internal fixation, the device supports bone healing and restores structural integrity to the radius. It serves as an alternative to external fixation or percutaneous pinning, particularly in cases of failed prior fixation or complex fracture patterns. The device is implanted surgically; the physician uses the system to stabilize the bone, which facilitates patient recovery and functional restoration of the wrist.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Flexible intramedullary implant; material: stainless steel; form factor: distal radius fixation plate/nail system; energy source: none (mechanical); connectivity: none; sterilization: not specified.

Indications for Use

Indicated for patients with unstable distal radius fractures requiring surgical fixation where closed reduction is unsuitable, including joint destruction/subluxation, malunion requiring osteotomy, non-displaced fractures requiring rigid stability, transverse fractures (AO A2, A3, C1), and failed prior fixation.

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 Locon-T Radial Plate System (K994061)
• Wright Radial Nail System (K040938)
• DVO Dorsal Intramedullary nail Plate (K042437)

Submission Summary (Full Text)

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## 510(k) Summary

Submitter's name Address

Phone Number Fax Number (revised)

Name of contact person Date summary was prepared

Proprietary name/Trade name Common Name

Classification Name

Predicate Device

Description of device

Intended use of device/Indications

Comparison to Predicate Device

Performance Data (Non clinical)

Sonoma Orthopedic Products, Inc. 650 Larkfield Center, Suite C Santa Rosa, CA 95403 707-526-1335 707-526-2022

Charles L. Nelson, Amy Conuel Original: June 28, 2007 Revised: February 14, 2008

EnsplintRy TM Intramedullary Distal Radius Fixation Device Plate, Fixation, Bone 21 CFR 888.3030

Wright Locon-T Radial Plate System K994061, cleared February 14, 2000 Wright Radial Nail System K040938 cleared July 1, 2004 DVO Dorsal Intramedullary nail Plate K042437, cleared Ocotber 8, 2004

The EnsplintRx™ configuration consists of a flexible implant manufactured from stainless steel.

The ENSPLINTRy™ Distal Radius System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:

- Joint destruction and/or subluxation visible on x-ray; .
- Osteotomy and repair of distal radius malunion with . or without bone graft;
- Non-displaced fractures in which the physician and . patient opt for rigid stability
- Transverse fractures of the distal radius with or . without comminution (e.g. AO classifications A2 and A3)
- Transverse fractures of the distal radius with an t extension into the joint without comminution (e.g. AO classification C1);
- Failed fracture fixation with or without bone graft for . the types of fractures above;
- The above types of fractures (i.e. AO classifications . non-displaced transverse, A2, A3, and C1) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.

The EnsplintRx TM has similar intended use, performance characteristics, and materials to the predicate device. The results of the non-clinical (bench top)

laboratory testing demonstrate that the device us substantially equivalent. Clinical evaluation of the device is not required.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.

Public Health Service

FEB 21 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sonoma Orthopedic Products, Inc. % Mr. Charles L. Nelson 650 Larkfield Center, Suite C Santa Rosa, CA 95403

Re: K071809 Trade/Device Name: ENSPLINTRx Distal Radius System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HSB Dated: January 30, 2008 Received: January 31, 2008

Dear Mr. Nelson:

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.

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.

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.

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Page 2 - Mr. Charles L. Nelson

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours.

Mark N. Mulhausen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

K071809 510(k) Number (if known):

Device Name: ENSPLINTRx™ Distal Radius System

Indications for Use

## INDICATIONS

The ENSPLINTRx™ Distal Radius System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:

- Joint destruction and/or subluxation visible on x-ray; .
- Osteotomy and repair of distal radius malunion with or without bone graft; .
- Non-displaced fractures in which the physician and patient opt for rigid stability .
- Transverse fractures of the distal radius with or without comminution (e.g. AO . classifications A2 and A3)
- Transverse fractures of the distal radius with an extension into the joint without . comminution (e.g. AO classification C1);
- Failed fracture fixation with or without bone graft for the types of fractures above; .
- The above types of fractures (i.e. AO classifications non-displaced transverse, A2, . A3, and C1) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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Division of General, Restorative, and Neurological Devices

510(k) Number K071809