PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,

K000515 · Interpore Cross Intl. · MQV · Sep 15, 2000 · Orthopedic

Device Facts

• Record ID: K000515
• Device Name: PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,
• Applicant: Interpore Cross Intl.
• Product Code: MQV · Orthopedic
• Decision Date: Sep 15, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Pro Osteon® 200R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Pro Osteon 200R is indicated to be gently packed 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 graft substitute that resorbs and is replaced with bone during the healing process.

Device Story

Pro Osteon 200R is an osteoconductive, porous calcium carbonate bone graft substitute with a thin calcium phosphate coating (2-10 microns). It mimics human cancellous bone structure with interconnected pores (190-230 microns). Used by surgeons in clinical settings to fill non-structural bony voids or gaps in the extremities, spine, and pelvis. The device is packed into the defect; it acts as a scaffold for tissue infiltration and bone apposition. As the calcium phosphate layer and underlying calcium carbonate matrix resorb, they are replaced by new bone and soft tissue. It provides no mechanical support; rigid fixation is required. Radiopacity allows visualization but may mask underlying pathology or new bone growth. Benefits include providing a resorbable matrix for natural bone healing.

Clinical Evidence

No clinical data provided. Evidence consists of nonclinical bench testing and animal studies to support substantial equivalence to the predicate device.

Technological Characteristics

Porous calcium carbonate matrix with 2-10 micron calcium phosphate surface coating. Trabecular structure with 190-230 micron interconnected pore diameter. Supplied sterile in various shapes/sizes. Radiopaque. Non-load bearing; requires rigid fixation.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities, spine, pelvis) not intrinsic to bony stability. Defects may be surgically created or traumatic. Contraindicated for growth plate fractures, segmental defects, sites subject to excessive stress, vascular impairment, metabolic/systemic bone disorders, unstable fractures, or infected sites.

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 Graft Substitute (K980817)

Submission Summary (Full Text)

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# SEP 1 5 2000

K000515

# 510(k) SUMMARY

### SUBMITTED BY

Prosie Rey-Fessler Director, Regulatory Affairs & Quality Assurance Interpore Cross International 181 Technology Drive Irvine, California 92618 [phone]

February 14, 1999 Date Submitted:

# CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

| Classification Name: | Bone Void Filler |
|-------------------------|---------------------------------------------------|
| Common/Usual Name: | Bone Void Filler or Bone Graft Substitute |
| Product Classification: | Unclassified |
| Proprietary Name: | Pro Osteon® 200R Resorbable Bone Graft Substitute |

### PREDICATE DEVICE

Interpore Cross International's Pro Osteon 500R Resorbable Bone Graft Substitute [reference 510(k) K980817]

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

# DEVICE DESCRIPTION AND MATERIALS OF CONSTRUCTION

Pro Osteon 200R Resorbable Bone Graft Substitute is an osteoconductive porous calcium carbonate implant similar in structure to human cancellous bone. It is supplied sterile in various shapes and sizes.

Pro Osteon 200R Resorbable Bone Graft Substitute has a trabecular structure with multidirectional interconnected porosity with an approximate pore diameter of 190 - 230 microns. The product consists of an underlying calcium carbonate matrix covered by a very thin outer layer of calcium phosphate, approximately 2 to 10 microns in thickness. The calcium phosphate is located on the outer surface of the porosity throughout the entire structure of the implant. Once implanted, the calcium phosphate outer layer will slowly resorb, delaying exposure of the underlying and faster

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resorbing calcium carbonate.

When Pro Osteon 200R is placed in direct contact with viable bone, the reticulated spaces in the implant are infiltrated with tissue. Bone formation occurs in apposition to the calcium phosphate surface and within the interstices of the implant skeleton. As the implant resorbs, bone and soft tissue grow into the space previously occupied by the calcium carbonate.

### INDICATIONS FOR USE

Pro Osteon 200R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Pro Osteon 200R is indicated to be gently packed 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 graft substitute that resorbs and is replaced with bone during the healing process.

#### PRECAUTIONS AND CONTRAINDICATIONS. WARNINGS, COMPLICATIONS

#### Contraindications 1.

Pro Osteon 200R is contraindicated for fractures of the growth plate; for segmental defects; for indications which may be subjected to excessive impact or stresses; when there is significant vascular impairment proximal to the graft site; when there are metabolic or systemic disorders that affect bone or wound healing; when stabilization of the fracture is not possible; in cases where intraoperative soft tissue coverage is not planned or possible, and in infected sites.

#### Warnings and Precautions 2.

Pro Osteon 200R does not possess sufficient mechanical strength to support reduction of a defect site prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure rigid stabilization of the defect in all planes. Pro Osteon 200R Resorbable Bone Graft Substitute is intended for use by surgeons familiar with bone grafting and rigid fixation techniques. Complete postoperative wound closure is essential.

Pro Osteon 200R is radiopaque until resorbed. Radiopacity may mask underlying pathological conditions. Radiopacity may also make it difficult to radiographically assess the ingrowth of new bone.

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#### 3. Complications

Potential complications using this device are the same as those encountered in autogenous bone grafting procedures and include the following: superficial wound infection, deep wound infection, deep wound infection with osteomyelitis, nonunion, wound dehiscence, delayed union, malunion, loss of reduction, refracture, cyst recurrence, hematoma, and cellulitis.

## COMPARISON TO THE PREDICATE DEVICE

The Pro Osteon 200R Resorbable Bone Graft Substitute product design, materials of construction or chemical composition, and function as a bone void filler or bone graft substitute are substantially equivalent to the predicate device. Pro Osteon 500R Resorbable Bone Graft Substitute.

### TESTING SUMMARY

Results of nonclinical testing, including bench testing and animal studies, support substantial equivalence of Pro Osteon 200R Resorbable Bone Graft Substitute to the predicate device, Pro Osteon 500R Resorbable Bone Graft Substitute.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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SEP 1 5 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Prosie Rey-Fessler Director, Quality Assurance and Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618

Re: K000515

Trade Name: ProOsteon 200R Regulatory Class: Unclassified Product Code: MQV Dated: June 16, 2000 Received: June 19, 2000

Dear Ms. Rey-Fessler:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have hove have determined the device is substantially equivalent (for the indications for use ato ve and in the enclosure) to legally marketed predicate devices marketed in interstate commerce stated in the energials, to regary and date of the Medical Device Amendments, or to devices that prior to frab, 20, 1976, and in the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control Costions of the Act. The general control provisions of the Act include requirements for annual provisions of the Fred - 12.0 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations ( Fecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mopely with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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# Page 2 - Ms. Prosie Rey-Fessler

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you deally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for questions on the promotion and advertising of your device, (2017 59 1 100 m = 100 m = 100 m = 100 m = 100 m = 100 m = 10 m = 10 m = 10 m = 10 m = 10 m = 10 = 10 = 1 entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mountation on your responsible [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Dume R. lochner

Image /page/4/Picture/4 description: The image shows a handwritten signature or symbol on the left, followed by the letters "C" and "D" on the right. The signature appears to be a stylized combination of curves and lines. The letters "C" and "D" are in a simple, sans-serif font and are vertically aligned.

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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# K000515

### 510(k) Number (if known):

Pro Osteon® 200R Resorbable Bone Graft Substitute Device Name:

### Indications for Use:

Pro Osteon® 200R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Pro Osteon 200R is indicated to be gently packed 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 graft substitute 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)

Durne

(Division Sign-Off) Division of Gener Restorative Devices 510(k) Number_K000515

Prescription Use \$\underline{\text{V}}\$
(PER 21 CFR 801.109)

OR

Over-The-Counter Use

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