SONICWELD RX (RESORB-X)

K080862 · KLS-Martin L.P. · JEY · Jul 21, 2008 · Dental

Device Facts

• Record ID: K080862
• Device Name: SONICWELD RX (RESORB-X)
• Applicant: KLS-Martin L.P.
• Product Code: JEY · Dental
• Decision Date: Jul 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The KLS Martin SonicWeld RX (Resorb-X) is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, plates, screws and pins may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation. The KLS Martin SonicWeld RX (Resorb-X) is not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine.

Device Story

Resorbable fixation system (pins, plates, screws) for craniofacial/mandibular reconstruction; utilizes ultrasonic energy via SonicWeld Rx Sonotrode device to induce phase transition in PDLLA pins; pins adapt to pilot holes and utilize bone micro-undercuts for retention. Used by surgeons in clinical settings. Provides mechanical stabilization of bone fragments/grafts. Benefits include resorbable material eliminating need for secondary removal surgery. Not for load-bearing unless combined with rigid fixation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarity to predicate devices.

Technological Characteristics

Materials: Poly (D, L) -Lactide-Acid (PDLLA). Sensing/Actuation: Ultrasonic energy via Sonotrode device to induce phase transition for pin retention. Form factor: Resorbable pins, plates, screws, and meshes. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for fracture repair and reconstruction of craniofacial skeleton in pediatric and adult populations; non-load bearing applications for maintaining position of bony fragments, bone grafts, or substitutes in craniofacial or mandibular areas. Contraindicated for active/latent infection, limited blood supply, insufficient bone quality/quantity, and spinal use.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Predicate Devices

• Resorb-X Resorbable Plating System (K011590)
• Resorb-X SF (K051236)
• Synthes (USA) Rapid Resorbable Fixation System (K062789)

Submission Summary (Full Text)

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# KO80862

:

# kıs martın LP.

:

JUL 2 1 2008

## 510(K) SUMMARY

| Submitter: | KLS-Martin, L.P.<br>11239-1 St. Johns Industrial Parkway South<br>Jacksonville, FL 32246<br>Phone: [phone]<br>Fax: [phone] | | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Tom Faucett<br>RA/QA Supervisor | | |
| Date of Summary: | 18 March 2008 | | |
| Device Name: | SonicWeld RX (Resorb-X) | | |
| Trade Name: | SonicWeld RX (Resorb-X) | | |
| Common Name: | Bone Plate | | |
| Classification<br>Name and Number: | Bone Plate (872.4760) | | |
| Regulatory Class: | II | | |
| Predicate Devices: | Resorb-X Resorbable Plating System<br>(K011590)<br><br>Resorb-X SF (K051236)<br><br>Synthes (USA) Rapid Resorbable Fixation<br>System (K062789) | | |
| Intended Use: | The KLS Martin SonicWeld RX (Resorb-X) is<br>intended for use in fracture repair and<br>reconstructive procedures of the craniofacial<br>skeleton in pediatric and adult populations. In<br>addition, resorbable meshes, plates, screws<br>and pins may be used in non-load bearing<br>applications for maintaining the relative<br>position of, and/or containing, bony fragments<br>bone grafts (autograft or allograft), or bone<br>graft substitutes in reconstruction of the<br>craniofacial or mandibular areas. | | |

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The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation. The KLS Martin SonicWeld RX (Resorb-X) is not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine.

The SonicWeld Rx pins are designed only to be inserted with the SonicWeld Rx Sonotrode device.

The SonicWeld RX (Resorb-X) is identical to RESORB-X® SF (K051236) which consists of RESORB-X® Pins made of Poly (D, L) -Lactide-Acid (PDLLA) of various diameters and lengths that are implanted utilizing ultrasonic force generated by an ultrasonic unit that causes a phase transition in the pin, allowing the pin to adapt to the previously drilled pilot hole in the surgical site and utilize the micro undercuts of the bone for retention. The RESORB-X® SF pins are designed to be used in conjunction with RESORB-X® Resorbable Plating System plates (K011590).

## Technological Characteristics:

#### Similarities to Predicate

The SonicWeld RX (Resorb-X) is identical to RESORB-X Resorbable Plating System (K011590) Resorb-X SF (K051236) in chemical composition.

The SonicWeld RX (Resorb-X) are the identical pins, screws and plates as the RESORB-X Resorbable Plating System (K011590) and Resorb-X SF (K051236) and are implanted in the identical manner.

#### Device Description:

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#### Differences to Predicate

This submission expands the indications for use to include use in non-load bearing applications in the mandible.

#### Substantial Equivalence:

The SonicWeld RX (Resorb-X)is substantially equivalent in intended use to the RESORB-X Resorbable Plating System (K011590), Resorb-X SF (K051236) and the Synthes (USA) Rapid Resorbable Fixation System (K062789)

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tom Faucett Senior Regulatory Affairs/ Quality Assurance Specialist KLS Martin L.P. 11239 St. Johns Industrial Parkway South Jacksonville Florida 32246

JUL 2 1 2008

Re: K080862

Trade/Device Name: SonicWeld RX (Resorb-X) Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 17, 2008 Received: June 18, 2008

Dear Mr. Faucett:

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.

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Page 2 - Mr. Faucett

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 chassification 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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Susan Runore

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K080862 510(k) Number (if known):

SonicWeld RX (Resorb-X) Device Name:

Indications For Use: The KLS Martin SonicWeld RX (Resorb-X) is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, plates, screws and pins may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation. The KLS Martin SonicWeld RX (Resorb-X) is not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine.

> The SonicWeld Rx pins are designed only to be inserted with the SonicWeld Rx Sonotrode device.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

Sue Kummer

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090562

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