DSM Biomedical DPR Cable

K143716 · Dsm Biomedical · JDQ · Oct 29, 2015 · Orthopedic

Device Facts

• Record ID: K143716
• Device Name: DSM Biomedical DPR Cable
• Applicant: Dsm Biomedical
• Product Code: JDQ · Orthopedic
• Decision Date: Oct 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DPR Cable is intended: - Spinal applications including sublaminar and intraspinous process wiring for trauma applications. - Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty. - Sternotomy indications including the "rewiring" of osteomized sternums. - Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring. The device is intended for single patient use only.

Device Story

DPR Cable is a flexible, multi-strand ultra-high molecular weight polyethylene (UHMWPE) cerclage cable used for stabilization of bony segments. Fibers incorporate bismuth trioxide for radiographic visualization. Device is supplied sterile for single-patient use. During surgery, clinician wraps cable around bone segments and secures via knot. Provides high-strength fixation for spinal, orthopedic, and sternal trauma applications. MR safe. Benefits include high tensile and fatigue strength compared to metallic cable systems, providing stable bone fixation.

Clinical Evidence

Bench testing only. Biomechanical testing included fatigue strength, tensile force, creep, wear-debris, and knot strength. Biocompatibility testing included cytotoxicity and leaching assessments. Results indicate performance equivalent to predicate and reference devices.

Technological Characteristics

Flexible, multi-strand UHMWPE (Dyneema Purity) fibers with bismuth trioxide (Bi2O3) for radiopacity. 4 mm diameter. Fixation via knot. Sterilized via EtO. Supplied in double-layer packaging. MR safe.

Indications for Use

Indicated for patients requiring bone fixation via cerclage, including spinal sublaminar/intraspinous wiring for trauma, trochanteric reattachment post-osteotomy, sternotomy rewiring, and fracture rewiring (olecranon, ankle, patella, shoulder). Single patient use only.

Regulatory Classification

Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

Predicate Devices

• Titanium Alloy Songer Cable System/ Atlas Cable System (K920201)

Reference Devices

• Iso-Elastic Cable (Kinamed Inc., K102834)
• Orthopedic Polyethylene Cable (Smith&Nephew, K924141)

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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, representing the department's focus on people and health.

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

October 29, 2015

DSM Biomedical Mr. Tom Maguire Senior Director Global Clinical and Regulatory 735 Pennsylvania Drive Exton, Pennsylvania 19341

Re: K143716

Trade/Device Name: DSM Biomedical DPR Cable Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: September 16, 2015 Received: September 17, 2015

Dear Mr. Maguire:

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 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.

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

Page 2 – Mr. Tom Maguire

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.

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}------------------------------------------------

Original 510(k) Premarket Notification DSM Biomedical DPR Cable

Image /page/2/Picture/2 description: The image shows the logo for DSM, a company focused on health, nutrition, and materials. The logo features a colorful, abstract circular design on the left, composed of overlapping shapes in shades of blue, purple, green, and orange. To the right of the circular design is the company name, "DSM," in bold, blue letters. Below the company name is the tagline, "BRIGHT SCIENCE. BRIGHTER LIVING."

#### Indications for Use Statement

The DPR Cable is intended for:

- Spinal applications include sublaminar and intraspinous process wiring for trauma ● applications.
- o Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
- Sternotomy indications including the "rewiring" of osteomized sternums.
- Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring.

The device is intended for single patient use only.

Prescription Use

Over-The-Counter Use__

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

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

Image /page/3/Picture/1 description: The image shows the DSM logo. The logo consists of a colorful abstract design on the left and the letters "DSM" in bold blue on the right. Below the letters, there is a tagline that reads "BRIGHT SCIENCE. BRIGHTER LIVING." in a smaller blue font.

# 510(k) Summary

| K143716 | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | DSM Biomedical<br>735 Pennsylvania Drive<br>Exton, PA 19341 |
| Contact Person: | Tom Maguire<br>Sr. Director, Global Clinical & Regulatory Affairs<br>E: [e-mail]<br>P: 484-713-2146<br>F: 484-713-2903 |
| Date Prepared: | October 26, 2015 |
| Device: | |
| Trade Name: | DPR Cable |
| Common/Usual Name: | Orthopedic Wire |
| Classification Name: | Bone Fixation Cerclage |
| Classification Regulation: | 21 CFR 888.3010 |
| Device Class: | Class II |
| Device Code: | JDQ |
| Advisory Panel: | General and Plastic Surgery |
| Predicate: | Titanium Alloy Songer Cable System/ Atlas Cable System<br>(Medtronic Sofamor Danek , K920201) |
| Reference Devices: | Iso-Elastic Cable (Kinamed Inc., K102834)<br>Orthopedic Polyethylene Cable (Smith&Nephew,<br>K924141) |

# Device Description:

The DPR Cable is a flexible, multi-strand ultra-high molecular weight polyethylene

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

(UHMWPE) cerclage cable. The device is intended to provide stabilization of bony segments.

The DPR Cable is made of woven ultra-high molecular weight polyethylene fibers which incorporate bismuth trioxide (Bi₂O₃). The addition of bismuth trioxide allows for radiographic visualization both during and after surgical procedures. The device is supplied sterile in double-layer packages. The DPR Cable is intended for single patient use only. DPR Cable is MR safe.

# Intended Use:

The DPR Cable is intended:

- Spinal applications including sublaminar and intraspinous process wiring for . trauma applications.
- . Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
- . Sternotomy indications including the "rewiring" of osteomized sternums.
- Trauma surgery indications including olecranon, ankle, patella and some shoulder . fracture rewiring.

The device is intended for single patient use only.

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

# Technological Characteristics:

| Characteristic | DSM Biomedical<br>DPR Cable<br>K143716 | Medtronic Sofamor Danek<br>Titanium Alloy Songer Cable<br>System/Atlas™ Cable System<br>K920201 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The DPR Cable is intended:<br>Spinal applications including<br>sublaminar and intraspinous<br>process wiring for trauma<br>applications. Trochanteric reattachment after<br>trochanteric osteotomy following<br>total hip arthroplasty. Sternotomy indications including<br>the “rewiring” of osteomized<br>sternums. Trauma surgery indications<br>including the olecranon, ankle,<br>patella and some shoulder<br>fracture rewiring. The device is intended for single<br>patient use only. | The Atlas™ Cable System can be utilized<br>anywhere monofilament wires have been<br>previously found to be indicated. The<br>indications are:<br>Spinal applications would include<br>sublaminar and intraspinous<br>process wiring for trauma<br>applications. Another<br>application would be the use of<br>Atlas™ Cable System for<br>instrumentation involved in the<br>correction of scoliotic,kyphotic<br>and lordotic deformities. The<br>stainless steel system may also<br>be used with other stainless steel<br>spinal implants such as the Unit<br>Rod or Luque Rod or wherever<br>"wiring" may help secure the<br>attachment of other implants.<br>The titanium system may also be<br>used with other titanium<br>implants. Trochanteric reattachment after<br>trochanteric osteotomy following |
| Characteristic | DSM Biomedical<br>DPR Cable<br>K143716 | Medtronic Sofamor Danek<br>Titanium Alloy Songer Cable<br>System/Atlas™ Cable System<br>K920201 |
| | | total hip arthroplasty.<br>Sternotomy indications would include the “re-wiring” of osteomizing sternums. Trauma surgery indications would include olecranon, ankle, patella and some shoulder rewiring. |
| Materials of<br>Composition | Dyneema Purity® UHMWPE and Bi2O3 | Titanium Steel and Titanium Alloy |
| Device<br>Characteristics | Flexible, high strength | High strength |
| Radiopaque | Yes | Yes |
| Fixation | Knot | Integral Crimp |
| Dimensions | 4 mm | 1 mm diameter |
| Tensile Strength<br>of fixated loop | 2289+/-35 | 1005+/-49 |
| Fatigue Strength | 1559N | <44.5N |
| Biocompatible | Yes | Yes |
| Reusable | Single Use Only | Single Use Only |
| Sterilization<br>Method | EtO | Irradiation |
| Packaging | Double layer | Not available |

{6}------------------------------------------------

{7}------------------------------------------------

### Biocompatibility and Performance Data:

# Biocompatibility testing

The biocompatibility of the materials used in the manufacturer of the DPR Cable, Dyneema Purity® fibers and bismuth trioxide, are established by their long historical clinical use in medical devices and the combination of these materials does not raise any new questions of safety and effectiveness. Cytotoxicity and leaching was performed on the Dyneema Purity® RP material.

Biomechanical testing included fatigue strength, tensile force, creep and wear-debris and knot strength. Testing results indicate that the device is equivalent to the predicate device.

#### Substantial Equivalence:

The DPR Cable is substantially equivalent in intended use, tensile strength, and fixation strength to the predicate device (Titanium Alloy Songer Cable System/Atlas™ Cable System, Medtronic Sofamor Danek, K920201). The DPR Cable is substantially equivalent to the material characteristics and creep and wear performance of the reference devices (Iso-Elastic Cable, Kinamed Inc., K102834 and Orthopedic Polyethylene Cable, Smith & Nephew, K924141).