CAMCERAM TCP

K050357 · Cam Implants B.V. · MQV · Apr 21, 2005 · Orthopedic

Device Facts

• Record ID: K050357
• Device Name: CAMCERAM TCP
• Applicant: Cam Implants B.V.
• Product Code: MQV · Orthopedic
• Decision Date: Apr 21, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CAMCERAM TCP is a resorbable bone void filler intended to fill bony void 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.

Device Story

CAMCERAM TCP is a porous, resorbable bone void filler composed of beta-Tricalcium Phosphate (beta-TCP). It is provided as granules (1-4 mm) or in block form. The device is used by surgeons to fill bony voids or gaps resulting from trauma or surgery in the extremities, spine, and pelvis. It is not intended to provide structural stability to the bony site. The material is designed to be resorbed by the body over time. It is a passive implantable device; no electronic, software, or algorithmic components are involved.

Clinical Evidence

Bench testing only. Conformance to ASTM F1088 standard for beta-Tricalcium Phosphate composition was demonstrated. No clinical study data provided.

Technological Characteristics

Material: Beta-Tricalcium Phosphate (conforms to ASTM F1088). Porosity: 90%. Form factor: Granules (1-4 mm) or blocks. Sterilization: Sterile. No software, electronics, or connectivity.

Indications for Use

Indicated for patients requiring bone void filling in extremities, spine, or pelvis due to trauma or surgery, where the defect is 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

• Vitoss scaffold (OrthoVita), K994337
• Conduit TCPgranules (Depuy Acromed), K01405

Submission Summary (Full Text)

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# 510(k) Summary for CAMCERAM TCP

## SPONSOR 1.

Name : CAM implants BV Address: Zernikedreef 6, Leiden, The Netherlands Contact Person: Kim Groenewegen van der Weijden Telephone: [phone] Facsimile: [phone]

Date Prepared: February 2005

# 2. DEVICE NAME

| Proprietary Name: | CAMCERAM TCP |
|----------------------|------------------|
| Common/Usual Name: | Bone void filler |
| Classification Name: | Bone void filler |

## 3. PREDICATE DEVICES

| Proprietary Name: | Vitoss scaffold (OrthoVita), K994337 |
|-------------------|---------------------------------------------|
| Proprietary Name: | Conduit TCPgranules (Depuy Acromed), K01405 |

#### DEVICE DESCRIPTION 4.

CAMCERAM TCP is a porous calcium phosphate resorbable bone void filler for the repair of bony defects. The product comprises of a beta-Tricalcium Phosphate and is 90% porous. The product is provided sterile available in granules 1-4 mm and a block form.

# INTENDED USE ਨੰ

CAMCERAM TCP is a resorbable bone void filler intended to fill bony void 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.

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# TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The CAMCERAM TCP and the predicate devices are all similar in design, materials of construction and function. CAMCERAM TCP has been compared in physico-chemical testing with the predicate devices which confirmed the composition and resorption profile. The safety and biocompatibility testing performed for calcium phosphates and the long history of safe clinical use for tricalcium phosphate products support the safe use of CAMCERAM TCP. CAMCERAM TCP meets the applicable requirements of the FDA guidance documents on bone void fillers.

#### 7. TESTING

The CAMCERAM TCP is tested to conform to the recognized standard, ASTM F1088 "Standard Specification for Composition of Beta-Tricalcium Phosphate for suregical Implantation". The devices to which the CAMCERAM TCP claims substantial equivalence are the Vitoss scaffold (Orthovita) and Conduit TCP (Depuy Acromed) have been used safely for many years in the clinical environment.

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Public Health Service

APR 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Rutger Kuipers Manager QA/RA CAM Implants BV Zernikedreef 6 2333 CL Leiden The Netherlands

Re: K050357

R050337
Trade/Device Name: CAMCERAM TCP Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: February 14, 2005 Received: February 14, 2005

Dear Mr. Kuipers:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) prematice is substantially equivalent (for the indications referenced above and nave uctchimical the devices marketed predicate devices marketed in interstate for use stated in the enclosure, to regally manced prouther and the Federal Food. Food Drug commerce prior to May 28, 1970, the enaement auto of the Federal Food. Drug, devices that have been reclassified in accerative what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket of the Act, and Cosment Act (Act) that to not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, listing of You may, therefore, market the devreet, belyer to the go
general controls provisions of the Act include requirements for annual registration, and general controls provisions of the rectments of the received in the branding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) inlove in the existing your device can
may be subject to such additional controls. Existing major regulation EDA may may be subject to such additional controls. Existing major of 998. hr addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Feach. Feegaring your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualitat equires with other requirements of the Act
that FDA has made a determination that your device and concension - You must that FDA has made a decemination that your administered by other Federal agencies. You must or any Federal statutes and regulations daminders on registration and listing (21
comply with all the Act's requirements, including, but not limited to: returnments as set comply with an the Act s requirements, mercements are many of course requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing and if continently, the CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Party 21 CFR 1000 (1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Mr. Rutger Kuipers

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/industry/support/index.html.

Sincerely yours,

Stipt Rurdy

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: CAMCERAM TCP Bone Void Filler

Indications for Use:

CAMCERAM TCP is a bone void filler is a resorbable implant intended to fill bony void 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.

Prescription Use _ X__________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stupt Rlurlu

(Divisio Division of General, Restorative. and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________