SKAFFOLD NMX BONE VOID FILLER

K132211 · Skeletal Kinetics, LLC · MQV · Aug 4, 2014 · Orthopedic

Device Facts

• Record ID: K132211
• Device Name: SKAFFOLD NMX BONE VOID FILLER
• Applicant: Skeletal Kinetics, LLC
• Product Code: MQV · Orthopedic
• Decision Date: Aug 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2

Intended Use

SKaffold NMX is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SKaffold NMX is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Device Story

SKaffold NMX is a pre-mixed, moldable, biocompatible bone void filler putty/paste. Composed of calcium phosphate powder in a bioinert polyethylene glycol (PEG) polymer carrier. Intended for use by surgeons to fill non-structural bony voids or gaps in the extremities and pelvis. Applied directly to the defect site; resorbs over time and is replaced by host bone during the healing process. Provided sterile for single-use in 5 cc and 10 cc kits. Benefits patient by facilitating bone ingrowth and natural healing in osseous defects.

Clinical Evidence

No clinical data. Evidence consists of bench testing and in vivo pre-clinical large animal studies (rabbit cancellous bone defect model). Bench testing compared chemistry (FTIR, XRD), crystallinity (XRD), physical form (SEM), porosity (Mercury Intrusion Porosimetry), and solubility (ICP-AES). Animal studies at 4 and 12 weeks demonstrated gradual remodeling, host bone replacement, and normal healing without abnormal tissue response.

Technological Characteristics

Calcium phosphate powder in bioinert polyethylene glycol (PEG) polymer carrier. Moldable putty/paste form. Sterilized via radiation (25kGy - 40kGy) per ISO 11137-2006. Biocompatibility tested per ISO 10993-1.

Indications for Use

Indicated for filling bony voids or gaps in the skeletal system (extremities and pelvis) that are not intrinsic to structural stability. Applicable to surgically created osseous defects or those resulting from traumatic injury. Contraindicated for defects requiring structural support.

Regulatory Classification

Identification

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

Predicate Devices

• Callos Bone Void Filler (K051123)

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

August 4, 2014

Skeletal Kinetics® LLC Ms. Christine Kuo. Director, Regulatory Affairs and Ouality Assurance 10201 Bubb Road Cupertino, California 95014

Re: K132211

Trade/Device Name: SKaffold NMX Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 17, 2014 Received: July 18, 2014

Dear Ms. Kuo:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/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 vours.

# Lori A. Wiggins

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Section 4: Indications for Use

K132211 510(K) Number (if Known):

Device Name: SKaffold NMX

Indications for Use:

SKaffold NMX is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SKaffold NMX is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The device provides a bone void filler that resorbs and is replaced by bone during the healing process.

X Prescription Use (Per 21 CFR 801 Subpart D)

Over-the-Counter Use (21CFR 801 Subpart C

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -A

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132211

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Image /page/3/Picture/0 description: The image shows the logo for Skeletal Kinetics. The logo consists of a blue globe-like icon on the left and the words "Skeletal Kinetics" in blue on the right. Below the logo is the text "A COLSON ASSOCIATE" in a smaller font.

# 510(k) Summary

General Information as required by 21 CFR 807.92 (a) (1)

| Submitters Name/Address: | Skeletal Kinetics® LLC<br>10201 Bubb Road<br>Cupertino, CA 95014, USA |
|--------------------------|-----------------------------------------------------------------------|
|--------------------------|-----------------------------------------------------------------------|

Date: August 4, 2014

Contact Person: Christine Kuo, Director, Regulatory Affairs and Quality Assurance Phone: [phone] Fax: [phone]

## Device Name as required by 21 CFR 807.92 (a) (2)

| Trade Name: | SKaffold NMX |
|--------------------|-------------------------------------------------|
| Regulation Number: | 21 CFR 888.3045 |
| Regulation Name: | Resorbable calcium salt bone void filler device |
| Regulatory Class: | II |
| Product Code: | MQV |

### Predicate Devices as required by 21 CFR 807.92 (a) (3)

The subject device is substantially equivalent in safety and effectiveness to the following legally marketed device (predicate) - Callos Bone Void Filler (K051123).

### Device Description as required by 21 CFR 807.92 (a) (4)

SKaffold NMX is a pre-mixed moldable and biocompatible putty/paste bone void filler. SKaffold NMX consists of a mixture of calcium phosphate powder in a bioinert polyethylene glycol (PEG) based polymer that resorbs and is replaced with bone during the healing process. The 5 cc and 10 cc SKaffold NMX kits are provided sterile and are for single use only.

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## Intended Use as required by 21 CFR 807.92 (a) (5)

SKaffold NMX is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SKaffold NMX is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

# Summary of Technological Characteristics as required by 21 CFR 807.92 (a) (6)

SKaffold NMX consists of moldable, biocompatible, resorbable calcium phosphate based material that can be applied directly to the intended sites. The polymer carrier used in SKaffold NMX is bioinert and biocompatible with host tissue and presents no new safety issues.

The intended use, and critical specifications (chemistry, crystallinity, physical form, porosity, and solubility) of SKaffold NMX are substantially equivalent to the predicate device, Callos Bone Void Filler (K051123).

# Summary of Non-clinical Tests as required by 21 CFR 807.92 (b) (1)

Critical specifications (chemistry, crystallinity, physical form, porosity, and solubility) of SKaffold NMX were compared with those of Callos Bone Void Filler (K051123). Chemistry was determined by Fourier Transformed Infrared Spectroscopy (FTIR) and Xray Diffraction (XRD) techniques. Crystallinity was determined by X-ray Diffraction. Physical form was determined by Scanning Electron Microscopy. Porosity was determined by Mercury Intrusion Porosimetry. Solubility was measured by in vitro dissolution method measuring Ca2+ ion concentration in solution using Inductively Coupled Plasma - Atomic Emission Spectroscopy. Performance test results demonstrated that SKaffold NMX has substantially equivalent critical specifications (chemistry, crystallinity, physical form, porosity, and solubility) as the predicate device Callos Bone Void Filler (K051123).

SKaffold NMX biocompatibility testing was performed in accordance with the standards set forth in ISO 10993-1, Biological Evaluation of Medical Devices and the test results demonstrated that SKaffold NMX met the requirements of the ISO standards.

In vivo, pre-clinical, large animal studies were performed in a cancellous bone defect model and showed gradual remodeling and replacement of implanted material by host bone. Histological, radiographic and histopathologic analyses were performed at 4 and 12 weeks that showed normal bone healing at the periphery of the cylindrical defects. No abnormal tissue responses were noted to the implanted device.

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SKaffold NMX will be provided as a single use. sterile product. The radiation dose of 25kGy - 40 kGy will be validated in accordance with ISO 11137-2006, Sterilization of Health Care Products - Radiation to Sterility Assurance Level (SAL) 10°.

The results of risk management indicate that the identified hazards were acceptable and/or mitigated to an acceptable level with the residual risk evaluation deemed as acceptable per defined procedures.

Non-clinical animal data in a well defined rabbit model demonstrated that SKaffold NMX is resorbed over time and allows bone ingrowth as the device is resorbing. SKaffold NMX maintains the previously demonstrated safety profile of the predicate device and is substantially equivalent to Callos Bone Void Filler (K051123).

# Summary of Clinical Tests as required by 21 CFR 807.92 (b) (2)

SKaffold NMX does not require clinical test.

# Conclusion as required by 21 CFR 807.92 (3)

The manufacturer compared the critical specifications - chemistry, crystallinity, physical form, porosity, dissolution/solubility of SKaffold NMX with the predicate device. The results indicated that the device characteristics for SKaffold NMX were the same as those of the predicate device. Therefore, SKaffold NMX bone void filler is substantially equivalent to the predicate device, Callos Bone Void Filler (K051123).