NAME BONE VOID FILLER

K041421 · Stryker Biotech · MQV · Aug 26, 2004 · Orthopedic

Device Facts

• Record ID: K041421
• Device Name: NAME BONE VOID FILLER
• Applicant: Stryker Biotech
• Product Code: MQV · Orthopedic
• Decision Date: Aug 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Stryker® TCP Putty is indicated as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. It should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Stryker® TCP Putty is intended to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis). Following placement in the bony void or gap, Stryker® TCP Putty is resorbed and replaced with bone during the healing process.

Device Story

Stryker® TCP Putty is an absorbable, osteoconductive bone void filler; composed of porous tri-calcium phosphate granules and carboxymethylcellulose (CMC) putty additive. Device acts as a scaffold for new bone in-growth; putty consistency allows manual conformation to defect shapes. Used by surgeons in clinical settings to fill bony voids or gaps in extremities, spine, and pelvis. Implant is packed into defects; resorbed and replaced by host bone during healing. Benefits include scaffold support for natural bone regeneration in non-load-bearing applications.

Clinical Evidence

No clinical data. Evidence provided via laboratory and animal testing to characterize device performance and demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Composition: Porous tri-calcium phosphate granules and carboxymethylcellulose (CMC) binder. Form: Putty. Principle: Osteoconductive scaffold. Resorbable. No electronic components or software.

Indications for Use

Indicated for patients with surgically created osseous defects or traumatic osseous defects in the skeletal system (extremities, spine, pelvis) requiring a bone void filler. Not for use in defects intrinsic to bony stability or large defects unlikely to heal spontaneously.

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

• Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler (K994337)
• BIOSORB® Resorbable Void Filler (K021963)
• JAX™ Bone Void Filler (K010555)
• Allomatrix Putty (K020895)

Submission Summary (Full Text)

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# K041421

# AUG 2 6 2004

## 510(k) Summary :

| Proprietary Name: | Stryker® TCP Putty |
|------------------------|-------------------------------------------------------------------------------------------|
| Common Name: | Bone Void Filler |
| Classification Name: | Resorbable calcium salt bone void filler<br>device |
| Reference: | 21 CFR 888.3045 |
| Device Product Code: | MQV - Filler, Calcium,<br>Preformed Pellet |
| Submitted By: | Stryker Biotech<br>35 South Street<br>Hopkinton, MA 01748 |
| Contact Information: | Sharon McDermott<br>Regulatory Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | 27 May 2004 |

#### Device Description:

Stryker® TCP Putty is an absorbable bone void filler composed of porous tri-calcium phosphate granules and carboxymethylcellulose, sodium (CMC) putty additive. It is an osteoconductive implant with a multidimensional porosity similar to human cancellous bone and acts as a scaffold for the in-growth of new bone and other connective tissues. The putty consistency allows the shape of the implant to conform to the defect, maximizing direct contact with viable host bone.

#### Intended Use:

Stryker® TCP Putty is indicated as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. It should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Stryker® TCP Putty is intended to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis). Following placement in the bony void or gap, Stryker® TCP Putty is resorbed and replaced with bone during the healing process.

#### Summary of substantial equivalence:

The intended use, materials, device performance and physical characteristics of Stryker® TCP Putty are substantially equivalent to those found in one or more of the following predicate devices.

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K994337: Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler_(Orthovita, Inc.)

K021963: BIOSORB® Resorbable Void Filler (Sciences et Bio Materiaux)

K010555: JAX™ Bone Void Filler (Smith & Nephew, Inc.)

K020895: Allomatrix Putty (Wright Medical Technology, Inc.)

#### Testing Summary

Laboratory testing and animal testing were provided to characterize the subject device and to allow comparison of its characteristics to predicate devices.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 6 2004

Ms. Sharon McDermott Regulatory Affairs Specialist Stryker Biotech 35 South Street Hopkinton, MA 01748

Re: K041421

Stryker® TCP Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: May 27, 2004 Received: May 28, 2004

Dear Ms. McDermott:

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

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# Page 2 - Ms. Sharon McDermott

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 promainer neted 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), r you 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 may overn 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/dsma/dsmamain.html

Sincerely vours.

Mark N. Millhusan

Celia M. Witten, Ph.D., M.D. 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

510(k) Number (if known): K041421

Stryker® TCP Putty Device Name:

Indications For Use:

TCP Putty is indicated as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or stations defects resulting from traumatic injury. It should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

TCP Putty is intended to be gently packed into bony voids or gaps of the skeletal system 1 cr 1 any is mittingul to 5 gelpelvis). Following placement in the bony void or gap, the tri-calcium phosphate scaffold is resorbed and replaced with bone during the healing process.

Prescription Use: X AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices Page 1 of 1

| 510(k) Number | K041421 |
|---------------|---------|
|---------------|---------|