SYNTHES CHRONOS COMPOSITE

K071046 · Synthes (Usa) · MQV · Oct 23, 2007 · Orthopedic

Device Facts

• Record ID: K071046
• Device Name: SYNTHES CHRONOS COMPOSITE
• Applicant: Synthes (Usa)
• Product Code: MQV · Orthopedic
• Decision Date: Oct 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes chronOS Composite is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Synthes chronOS Composite is indicated for use in the treatment of bony defects created surgically or through traumatic injury. Synthes chronOS Composite, combined with autogenous blood and/or bone marrow or autograft, is intended to be used in spine for posterolateral fusion. Following placement into the bony void, chronOS Composite resorbs and is replaced with bone during the healing process.

Device Story

Synthetic, porous, osteoconductive, resorbable bone void filler; composed of beta-tricalcium phosphate (β-TCP) granules embedded in poly(lactide-co-ε-caprolactone) matrix. Flexible, moldable material allows surgeon to contour device to bony implant site. Used in surgical settings for filling bony defects or posterolateral spine fusion. Implanted by surgeon; resorbs over time and is replaced by natural bone during healing process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Synthetic bone void filler; β-TCP granules in poly(lactide-co-ε-caprolactone) matrix. Osteoconductive, resorbable. Flexible, moldable form factor. No electronic components or software.

Indications for Use

Indicated for patients with bony voids or gaps not intrinsic to bony stability, resulting from surgical procedures or traumatic injury. Also indicated for use in spine for posterolateral fusion when combined with autogenous blood, bone marrow, or autograft.

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

• Synthes (USA) chronOS™ (K043045)
• chronOS TCP (K013072)

Submission Summary (Full Text)

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K071046

## 0CT 2 3 2007

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| 510(k) Summary | | OCT 23 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Submitter: | Synthes Biomaterials<br>1230 Wilson Drive<br>West Chester, PA 19380 | |
| Company Contact: | Jeffrey L. Dow, JD<br>Director, Clinical & Regulatory Affairs<br>Synthes Biomaterials<br>484 356 9720<br>[e-mail] | |
| Name of Device: | Synthes chronOS Composite | |
| Device Classification: | Class II, 21 CFR § 888.3045 | |
| Product Code: | MQV | |
| Common Name: | Resorbable Calcium Salt Bone Void Filler | |
| Predicate Devices: | Synthes (USA) chronOS™ (K043045)<br>chronOS TCP (K013072) | |
| Intended Use: | Synthes chronOS Composite is indicated for bony<br>voids or gaps that are not intrinsic to the stability of<br>the bony structure. Synthes chronOS Composite is<br>indicated for use in the treatment of bony defects<br>created surgically or through traumatic injury.<br><br>Synthes chronOS Composite, combined with<br>autogenous blood and/or bone marrow or autograft, is<br>intended to be used in spine for posterolateral fusion.<br>Following placement into the bony void, chronOS<br>Composite resorbs and is replaced with bone during<br>the healing process. | |
| Device Description: | Synthes chronOS Composite is a synthetic, porous,<br>osteoconductive, resorbable bone void filler made<br>from chronOS ß-TCP granules imbedded in a matrix<br>of poly (lactide-co-ε-caprolactone). The composite<br>is flexible and may be molded by the surgeon or<br>used directly as supplied. The flexible chronOS<br>Composite provides contourability and malleability<br>of the device to the bony implant site. | |

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Substantial Equivalency:

Documentation is provided which demonstrates that Synthes chronOS Composite is substantially equivalent to other legally marketed Synthes devices.

^&#x27; The term "substantial equivalence" as used in the 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended, and as applied under 21 CFR Part 807, Subpart E, under which a devices an be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an adminission against interest under the US patent laws or their application by the courts

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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 stylized representation of a human figure with three faces in profile, stacked on top of each other. The faces are depicted in a flowing, abstract manner. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUI 2 3 2007

Synthes Biomaterials % Jeffrey L. Dow, JD 1230 Wilson Drive West Chester, PA 19380

Re: K071046

Trade/Device Name: Synthes chronOSTM B-TCP Composite Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: October 18, 2007 Received: October 22, 2007

Dear Mr. Dow:

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 - Jeffrey L. Dow, JD

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 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Mulkern

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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## 2. Indications for Use

510(k) Number (if known): K 0 7 104 6

Device Name: Synthes chronOS™ Composite Indications: Synthes chronOS Composite is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Synthes chronOS Composite is indicated for use in the treatment of bony defects created surgically or through traumatic injury. Synthes chronOS Composite , combined with autogenous blood and/or bone marrow or autograft, is intended to be used in spine for posterolateral fusion. Following placement into the bony void, chronOS Composite resorbs and is replaced with bone during the healing process. Prescription Use X Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millman

KO71046

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

Synthes (USA) Premarket Notification 510(k) chronOS Composite

CONFIDENTIAL