NORIAN SRS BONE VOID FILLER

K011897 · Synthes (Usa) · MQV · Dec 20, 2001 · Orthopedic

Device Facts

• Record ID: K011897
• Device Name: NORIAN SRS BONE VOID FILLER
• Applicant: Synthes (Usa)
• Product Code: MQV · Orthopedic
• Decision Date: Dec 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Norian SRS Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Device Story

Norian SRS Bone Void Filler is an injectable, moldable, biocompatible bone void filler. It consists of a sterile powder (calcium phosphate) and a solution (dilute sodium phosphate) mixed in a reusable mixer to form a viscous paste. The paste remains injectable for approximately 5 minutes at room temperature; it begins to harden after 2 minutes and sets in approximately 10 minutes at body temperature. The device is intended for use by clinicians to fill non-structural osseous defects in the extremities, spine, and pelvis. The material is slowly resorbed over years and replaced by bone during the healing process. It is provided sterile for single use.

Clinical Evidence

No clinical data. Pre-clinical animal studies demonstrated that the device supports bone growth into metaphyseal defects, with material resorption accompanied by bone ingrowth and remodeling.

Technological Characteristics

Calcium phosphate powder and dilute sodium phosphate solution; injectable, moldable paste; sets at body temperature (37°C); biocompatible; resorbable; sterile, single-use.

Indications for Use

Indicated for patients with non-structural bony voids or gaps in the skeletal system, including extremities, spine, and pelvis, resulting from surgical procedures or traumatic injury.

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
• Pro Osteon® 500R Resorbable Bone Graft Substitute

Submission Summary (Full Text)

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## 510(k) Summary

DEC 2 0 2001

| Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Angela J. Silvestri<br>[phone] |
| Device Name: | Norian® SRS® Bone Void Filler |
| Device Classification: | 87 MQV - Unclassified - Filler, Calcium Sulfate Preformed Pellets |
| Predicate Device: | Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler<br>Pro Osteon® 500R Resorbable Bone Graft Substitute |
| Device Description: | Norian SRS Bone Void Filler is an injectable, moldable and<br>biocompatible bone void filler. The reactants pack contains sterile<br>powder (calcium phosphate) and solution (dilute sodium phosphate)<br>components. The reactants pack is designed to be placed in a reusable<br>mixer where the two components are mixed together to form a smooth,<br>viscous paste that remains injectable for approximately 5 minutes at 18<br>- 23°C. Norian SRS Bone Void Filler begins to harden after 2 minutes<br>and sets in approximately 10 minutes at body temperature (37°C).<br>Norian SRS Bone Void Filler is slowly resorbed over a period of<br>years. The 3cc, 5cc, and 10 cc reactants packs are provided sterile and<br>are for single use only. |
| Indications for use: | Norian SRS Bone Void Filler is intended only for bony voids or<br>defects that are not intrinsic to the stability of the bony structure.<br>Norian SRS Bone Void Filler is intended to be placed or injected into<br>bony voids or gaps of the skeletal system (i.e., the extremities, spine<br>and pelvis). These defects may be surgically created osseous defects<br>or osseous defects created from traumatic injury to the bone. The<br>product provides a bone void filler that resorbs and is replaced with<br>bone during the healing process. |
| Non-clinical<br>performance data: | Pre-clinical animal data demonstrate that Norian SRS Bone Void Filler<br>supports bone growth into a metaphyseal defect. These data show that<br>the materials compared resorb over a period of time, accompanied by<br>bone ingrowth and bone remodeling. These results, in conjunction<br>with biocompatibility data, demonstrate that Norian SRS Bone Void<br>Filler is as safe and effective as the predicate devices. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2001

Ms. Angela J. Silvestri Manager, Regulatory Affairs Synthes, (USA) 1690 Russell Road Paoli, Pennsylvania 19301

Re: K011897

Trade/Device Name: Norian® SRS® Bone Void Filler Regulatory Class: Unclassified Product Code: MQV Dated: October 9, 2001 Received: October 10, 2001

Dear Ms. Silvestri:

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 - Ms. Angela J. Silvestri

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oogin maneting your mance of your device of your device to a legally premarket notheation: "The PDF intellig sification 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 and If you desire specific acrise for you in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of Compilance at [phone]. The at Compliance at [phone]. Also, please note the your device, preads connervanding by reference to premarket notification" (21CFR Part 807.97). Tegulation clittied, "Misormation on your responsibilities under the Act may be obtained from the Outler general information on your respontional 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 yours,

Barbara Nyimumac for

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 Statement 2.0

Page of l of of ______________________________________________________________________________________________________________________________________________________________

| 510(k) Number (if known): | K011897 |
|---------------------------|---------|
|---------------------------|---------|

Norian® SRS® Bone Void Filler Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Norian SRS Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Rastena hummmer
Division Sign-Off

Division of General, Restorative and Neurological Devices

510(k) Number k011897

CONFIDENTIAL