PRO-DENSE BONE VOID FILLER

K070437 · Wrightmedicaltechnologyinc · MQV · May 9, 2007 · Orthopedic

Device Facts

• Record ID: K070437
• Device Name: PRO-DENSE BONE VOID FILLER
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MQV · Orthopedic
• Decision Date: May 9, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PRO-DENSE™ resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis) to cure in-situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process. The PRO-DENSE™ paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

Device Story

PRO-DENSE™ is a calcium sulfate/calcium phosphate composite bone graft substitute; supplied as powder and aqueous mixing solution. Components mixed to form injectable paste; injected or packed into non-structural bone voids/gaps in extremities, spine, or pelvis. Paste cures in-situ via hydration reactions. Used by surgeons to fill voids and augment provisional hardware (e.g., K-wires) during procedures. Acts as temporary support media; resorbs and is replaced by host bone during healing. Benefits include accelerated healing and remodeling into normal trabecular bone architecture.

Clinical Evidence

No human clinical data. Evidence based on a critically sized canine proximal humerus defect model. Study compared PRO-DENSE™ to autograft. Results at 13 weeks showed 645% increase in compressive strength and 170% increase in new bone formation (p-values not specified). At 26 weeks, PRO-DENSE™ remodeled to normal host bone with no significant difference in mechanical properties compared to normal bone.

Technological Characteristics

Calcium sulfate and calcium phosphate composite. Form factor: powder and aqueous mixing solution for in-situ curing paste. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for patients requiring bone graft substitution for open bone voids or gaps in the skeletal system (extremities, spine, pelvis) not intrinsic to structural stability. Used for surgically created osseous defects or traumatic bone injuries. Contraindicated for use where structural support is required during the healing process.

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

• MIIG® SR Bone Void Filler (K060011)

Submission Summary (Full Text)

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K070437
MAY - 9 2007

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of PRO-DENSE™ Bone Void Filler.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|---------------------------------------------------------------------------------|
| Date: | March 29, 2007 |
| Contact Person: | Ryan M. Belaney |
| | Regulatory Affairs Specialist I |
| Proprietary Name: | PRO-DENSE™ Bone Graft Substitute |
| Common Name: | Bone Graft Substitute |
| Classification Name and Reference: | 21 CFR 888.3045 - Resorbable Calcium Salt Bone Void<br>Filler Device - Class II |
| Device Product Code and Panel Code: | Orthopedic/87/MQV |

## DEVICE INFORMATION

#### A. INTENDED USE

PRO-DENSE™ resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis) to cure in-situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

The PRO-DENSE™ paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

#### B. DEVICE DESCRIPTION

The PRO-DENSE™ Bone Graft Substitute material is indicated as a bone graft substitute to be injected, digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system to cure in-situ. A brief description of the PRO-DENSE™ implant and a summary of additional performance/marketing claims are provided below.

#### IMPLANT DESCRIPTION

PRO-DENSE™ consists of a calcium sulfate - calcium phosphate composite bone graft substitute consisting of a powder component and an aqueous mixing solution. When the two components are mixed, according to directions, an injectable paste is formed which subsequently hardens via hydration reactions. The paste can be injected and cured in situ or gently packed into bony defects.

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### NON-CLINICAL PERFORMANCE/MARKETING CLAIMS

- *All claims are based on a critically sized canine proximal humerus defect model. It is unknown how results from the canine model compare with clinical results in humans.
- · Claim 1: The newly regenerated bone in the PRO-DENSE™ injectable treated defects exhibited a 645% average increase in compressive strength at 13 weeks versus defects treated with autograft: Stronger than autograft.*

Substantiation: Ultimate compressive strength in PRO-DENSE™ injectable increased 645% compared to the autograft group.

- · Claim 2: Histomorphometry reveals that the amount of newly regenerated bone of the PRO-DENSE™ injectable treated defects at 13 weeks demonstrated a statistically significant 170% average increase in new bone formation versus defects treated with autograft. PRO-DENSE™ injectable new bone area fraction is on average 170% denser than autograft at 13 weeks: Denser than autograft. *
Substantiation: Results showed that PRO-DENSE™ injectable demonstrated a 170% average increase in new bone volume over autograft treatment.

- · Claim 3: The accelerated rate of healing of the PRO-DENSE treated defects compared to those treated with autograft is principally evident by the higher density bone (i.e., 170% average increase in area fraction of new bone compared to autograft at 13 weeks) and superior average mechanical properties at 13 weeks: Faster than autograft. *
Substantiation: Results showed that PRO-DENSE™ injectable demonstrated a, statistically significant, 170% average in new bone volume over autograft treatment. Ultimate compressive strength and elastic modulus in PRO-DENSE™ injectable increased 645% and 600% respectively, compared to the autograft group.

- · Claim 4: Newly regenerated bone from the PRO-DENSE™ injectable treated defects remodeled to normal host bone, demonstrated by normal trabecular architecture histologically, and no significant difference in mechanical properties (compressive strength and modulus of elasticity) at the 26 week timepoint: Remodels to normal bone. *
Substantiation: Area fraction of new bone results of PRO-DENSE™ injectable showed no statistically significant difference to normal bone area fraction, indicating that the PRO-DENSE™ injectable has substantially remodeled toward the normal state of trabecular bone by 26 weeks. Additionally, ultimate compressive strength and modulus of elasticity of PRO-DENSE™ injectable at 26 weeks showed no statistically significant difference to normal bone samples.

- · Claim 5: The compressive modulus of the newly regenerated bone from the PRO-DENSE™ injectable treated defects at both 13 and 26 weeks falls within the published range for normal human cancellous bone: No modulus mismatch. *
Substantiation: An examination of published values of compressive modulus for human cancellous bone shows that even the highest value measured for PRO-DENSE™ injectable treated defects is still well within the range of normal cancellous bone.

## C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, type of interface, operating principles, shelf life, and design features of the PRO-DENSE™ Bone Graft Substitute are substantially equivalent to the previously cleared MIIG® SR Bone Void Filler 510(k): K060011. Additionally, the safety and effectiveness of the PRO-DENSE™ Bone Graft Substitute is adequately supported by the substantial equivalent information, materials data, and testing results provided within this Premarket Notification.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. % Mr. Ryan M. Belaney Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

MAY - 9 2007

Re: K070437

Trade/Device Name: PRO-DENSE™ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: April 6, 2007 Received: April 9, 2007

Dear Mr. Belaney:

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. Ryan M. Belaney

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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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. 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 Statement

K070437 510(k) Number:

PRO-DENSETM Device Name:

Indications For Use:

PRO-DENSE™ resultant paste is intended for use as a bone graft substitute to be injected or I KO-DENDE - - resultant parts is ds/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis) to cure in-situ. These open bone voids the skelem system. (ne, messeous defects or osseous defects created from traumatic injury to the may be surgically created obsears astesubstitute that resorbs and is replaced with bone during the healing process.

The PRO-DENSE™ paste cured in situ provides an open void/gap filler that can augment Inc I NO-DEADE - passe etc. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

PRO-DENSETM is provided sterile for single use only.

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Prescription Use ✓
(Per21 CFR 801.109)
510(k) Number 11070437

1070437

(Division Sign-Off)

Division of General Restorative Devices

510(k) Number

Over-The Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)