SYNTHES (USA) CHRONOS

K043045 · Synthes (Usa) · MQV · Jan 7, 2005 · Orthopedic

Device Facts

• Record ID: K043045
• Device Name: SYNTHES (USA) CHRONOS
• Applicant: Synthes (Usa)
• Product Code: MQV · Orthopedic
• Decision Date: Jan 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes chronOS™ is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. chronOS™ is indicated for use in the treatment of bony defects created surgically or through traumatic injury. Synthes chronOS™ is intended to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement into the bony void, chronOS™ resorbs and is replaced with bone during the healing process.

Device Story

Synthes chronOS™ is a porous, osteoconductive, resorbable bone void filler composed of β-Tricalcium Phosphate (TCP). Available in granules, blocks, wedges, and cylinders; provided sterile. Device is packed or placed into skeletal bony voids (extremities, spine, pelvis) by surgeons. May be mixed with patient's autogenous blood or bone marrow using an included perfusion syringe. Once implanted, the porous matrix facilitates bone ingrowth; material resorbs over time and is replaced by new bone during the healing process. Benefits include providing a scaffold for natural bone regeneration in non-structural defects.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and material properties.

Technological Characteristics

Material: β-Tricalcium Phosphate (TCP). Form: Porous granules, blocks, wedges, cylinders. Principle: Osteoconductive scaffold for bone ingrowth. Sterilization: Provided in double sterile pack. Includes perfusion syringe for mixing with blood/bone marrow.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities, spine, pelvis) not intrinsic to structural stability, 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

• Synthes chronOS™
• Orthovita, Inc. Vitoss® Scaffold Synthetic Cancellous Bone Void Filler and Imbibe II Syringe

Submission Summary (Full Text)

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## JAN - 7 2005

## 3.0 510(k) Summary

| Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes (USA) chronOS™ |
| Classification: | Class II, 21 CFR §888.3045<br>Filler, Calcium Sulfate Performed Pellets |
| | Class II, 21 CFR §880.5860<br>Piston Syringe |
| Predicate Device: | Synthes chronOS™<br>Orthovita, Inc. Vitoss® Scaffold Synthetic Cancellous Bone Void<br>Filler and Imbibe II Syringe |
| Device Description: | Synthes chronOS™ is a porous, osteoconductive, resorbable bone<br>void filler made from β-Tricalcium Phosphate (TCP). Synthes<br>chronOS™ is resorbed and replaced by new bone during the<br>healing process. The pore structure of chronOS™ provides a matrix<br>for the ingrowth of bone. chronOS™ is provided sterile in a double<br>sterile pack. It is available in various forms including granules,<br>blocks, wedges and cylinders. |
| | Synthes chronOS™ may be packaged with a perfusion syringe that<br>is used to mix the bone void filler with the patient's blood<br>components and/or bone marrow. |
| Intended Use: | Synthes chronOS™ is indicated for use in bony voids or gaps that<br>are not intrinsic to the stability of the bony structure. chronOS™<br>is indicated for use in the treatment of bony defects created<br>surgically or through traumatic injury. |
| | Synthes chronOS™ is intended to be gently packed or placed into<br>bony voids or gaps of the skeletal system (i.e. the extremities,<br>spine, and pelvis) and may be combined with autogenous blood<br>and/or bone marrow. Following placement into the bony void,<br>chronOS™ resorbs and is replaced with bone during the healing<br>process. |
| Substantial<br>Equivalence: | Documentation is provided which demonstrates that Synthes<br>chronOS™ is substantially equivalent* to other legally marketed<br>Synthes devices. |

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*The term "substantial equivalence" as used in the 510(k) notification is limited to the definition of substantial equivalence found in the Food, Drug and Cosmetic Act, as amended and as applied under 21 CRF 807, Subpart F, under which a device can 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 admission against interest under the US Patent Laws or their application by the courts.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2005

Ms. Kathy Anderson Regulatory Manager Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301

Re: K043045

Trade/Device Name: Synthes (USA) Chronos with Perfusion Syringe Regulation Number: 21 CFR 888.3045, 21 CFR 880.5860 Regulation Name: Resorbable calcium salt bone void filler, Piston Syringe Regulatory Class: II Product Code: MQV, FMF Dated: January 3, 2005 Received: January 4, 2005

Dear Ms. Anderson:

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. Kathy Anderson

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/dsma/dsmamain.html

Sincerely yours,

Willy Otto

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

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## Indications for Use

510(k) Number (if known):

Device Name:

K043045

Synthes (USA) chronOSTM

Indications:

Synthes chronOS™ is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Synthes chronOS™ is indicated for use in the treatment of bony defects created surgically or through traumatic injury.

Synthes chronOS™ is intended to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement into the bony void, chronOS™ resorbs and is replaced with bone during the healing process.

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Division of General, Restorative, and Neurological Devices

510(k) Number K043045

0004