CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)

K013072 · Synthes · MQV · Nov 26, 2002 · Orthopedic

Device Facts

• Record ID: K013072
• Device Name: CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)
• Applicant: Synthes
• Product Code: MQV · Orthopedic
• Decision Date: Nov 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes chronOS is intended for use as a bone void filler in 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. chronOS is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis). Following placement in the bony void or gap, the calcium phosphate scaffold 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). It features a uniform 3D pore structure with diameters ranging from 100 to 500 µm. Provided sterile in various forms (granules, blocks, cylinders, wedges), it is packed or placed into non-structural bony voids or gaps in the extremities, spine, or pelvis. An optional perfusion syringe allows mixing the filler with patient blood components before application. Once implanted, the scaffold resorbs and is replaced by natural bone during the healing process. Used by surgeons in clinical settings to treat bony defects.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: β-Tricalcium Phosphate [Ca3(PO4)2]. Structure: Porous scaffold with 100-500 µm pore diameters. Form: Granules, blocks, cylinders, wedges. Sterilization: Sterile. Accessory: Piston-style perfusion syringe.

Indications for Use

Indicated for patients with surgically created or traumatic bony defects in the skeletal system (extremities, spine, pelvis) requiring a bone void filler for gaps not intrinsic to bony stability.

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

• Pro Osteon 500R Resorbable Bone Void Filler
• Vitoss Scaffold Synthetic Bone Void filler

Submission Summary (Full Text)

{0}------------------------------------------------

Confidential

·

## K013072

# NOV 2 6 2002

.

### 510(k) Summary

| SPONSOR: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone]<br>Contact: Thomas M. Maguire |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | chronOS |
| CLASSIFICATION: | chronOS: Unclassified. Product Code is MQV.<br>Perfusion Syringe: Piston Syringe; Product Code is FMF. |
| PREDICATE DEVICE: | Pro Osteon 500R Resorbable Bone Void Filler<br>Vitoss Scaffold Synthetic Bone Void filler |
| DEVICE DESCRIPTION: | Synthes chronOS is a porous, osteoconductive, resorbable bone void filler<br>made from β-Tricalcium Phosphate (TCP). chronOS features a uniform<br>three dimensional pore structure. Pore diameters within the material range<br>from 100 to 500 µm. chronOS is provided sterile in granules and preformed<br>shapes (e.g. blocks, cylinders, wedges). <p>chronOS may be packaged with a perfusion syringe that is used to mix the<br/>bone void filler with the patient's blood components.</p> |
| INTENDED USE: | Synthes chronOS is intended for use as a bone void filler in voids or gaps<br>that are not intrinsic to the stability of the bony structure. chronOS is<br>indicated for use in the treatment of bony defects created surgically or<br>through traumatic injury. <p>chronOS is indicated to be gently packed or placed into bony voids or gaps<br/>of the skeletal system (i.e. the extremities, spine, and pelvis). Following<br/>placement in the bony void or gap, the calcium phosphate scaffold resorbs<br/>and is replaced with bone during the healing process.</p> |
| MATERIAL: | β-Tricalcium Phosphate [Ca3(PO4)2] |

{1}------------------------------------------------

#### DEPARTMENT OF HEALTH S

Image /page/1/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and appears to be part of a document or sign. The text is slightly faded, suggesting it may be from an older document or a low-resolution image.

9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas M. Maguire Regulatory Compliance Manager Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, PA 19301

Re: K013072

Synthes chronOS Tricalcium Phosphate and Synthes Perfusion Syringe Regulatory Class: unclassified Product code: MQV Dated: August 29, 2002 Received: August 30, 2002

Dear Mr. Maguire:

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

{2}------------------------------------------------

Page 2 – Mr. Thomas M. Maguire

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. 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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrl/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

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

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized image of a flower or plant inside of a circle. The logo and the word "SYNTHES" are the only elements in the image.

| <b>2.0</b> | <b>Indications for Use Statement</b> |
|------------|--------------------------------------|
|------------|--------------------------------------|

510(k) Number (if known):

K013072

Device Name: and the contract of the contract and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comme

Indications/Contraindications:

Synthes ChronOS is intended for use as a bone void filler for 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.

ChronOS Tricalcium Phosphate is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis). Following placement in the bony void or gap, the calcium phosphate scaffold 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

(Division Sign Off)

Page 1 __

sorative and Neurological ive

510/

K01307

Synthes (USA) Svstem Name 510(k) - ChronOS Confidential