PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L

K980817 · Interpore Intl. · MQV · Sep 25, 1998 · Orthopedic

Device Facts

• Record ID: K980817
• Device Name: PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L
• Applicant: Interpore Intl.
• Product Code: MQV · Orthopedic
• Decision Date: Sep 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Pro Osteon® 500R Resorbable Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Pro Osteon 500R 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 void filler that resorbs and is replaced with bone during the healing process.

Device Story

Pro Osteon 500R is an osteoconductive, porous, resorbable bone void filler; structure mimics human cancellous bone. Composed of trabecular calcium carbonate coated with thin calcium phosphate layer. Supplied sterile in various shapes/sizes. Used by surgeons familiar with bone grafting; packed into non-structural bony voids/gaps in extremities, spine, or pelvis. Implant provides scaffold for tissue infiltration and bone ingrowth; calcium phosphate layer resorbs slowly, followed by faster resorption of calcium carbonate substructure (within 6 months). Requires rigid fixation techniques for defect stabilization; does not provide mechanical support. Radiopaque; may mask pathology or complicate radiographic assessment of bone ingrowth. Benefits patient by facilitating natural bone healing and replacement of void space.

Clinical Evidence

No clinical data. Evidence based on animal testing (rabbit tibial defect model) demonstrating bone formation and resorption rates, dissolution studies comparing resorption to non-resorbable substitutes, and mechanical testing confirming compressive characteristics equivalent to trabecular bone. Testing confirmed non-pyrogenic and non-toxic status.

Technological Characteristics

Porous, trabecular calcium carbonate implant with 2-10 micron calcium phosphate surface coating. Median pore diameter 435 microns. Resorbable. Supplied sterile. Mechanical properties equivalent to trabecular bone. No software or electronic components.

Indications for Use

Indicated for filling bony voids or gaps in the skeletal system (extremities, spine, pelvis) not intrinsic to structural stability. Suitable for surgically created or traumatic osseous defects. Contraindicated for growth plate fractures, segmental defects, sites subject to excessive impact/stress, significant vascular impairment, metabolic/systemic bone/healing disorders, unstable fractures, sites requiring soft tissue coverage not planned, 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

• Wright Medical Osteoset™ Bone Void Filler (K960978 and K963562)

Submission Summary (Full Text)

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SEP 2 5 1998

510(k) Premarket Notification Pro Osteon 500R Resorbable Bone Void Filler

Interpore International - Confidential -K980817

SEP 2 5 1998

# APPENDIX 11

# 510(k) SUMMARY

# FOR

# PRO OSTEON® 500R RESORBABLE BONE VOID FILLER

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# 510(k) SUMMARY

#### SUBMITTED BY

David P. Balding Director, Quality Assurance and Regulatory Affairs INTERPORE International 181 Technology Drive Irvine, California 92618 [phone]

March 2, 1998 Date Submitted:

# CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

| Classification Name: | Bone Void Filler |
|-------------------------|----------------------------------------------|
| Common/Usual Name: | Bone Void Filler |
| Product Classification: | Unclassified |
| Proprietary Name: | Pro Osteon® 500R Resorbable Bone Void Filler |

### PREDICATE DEVICE

Wright Medical Osteoset™ Bone Void Filler (aka Wright Plaster of Paris Pellets) [reference 510(k)'s K960978 and K963562]

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 500R Resorbable Bone Void Filler is an osteoconductive porous implant similar in structure to human cancellous bone. It is supplied sterile in various shapes and sizes.

Pro Osteon 500R has a trabecular structure which resembles the multidirectional interconnected porosity of cancellous bone. It has a median pore diameter of 435 microns. The implant is trabecular calcium carbonate covered by a very thin outer layer of calcium phosphate representing approximately 13% of the total implant structure. The calcium phosphate is located on the outer surface of the porosity throughout the entire structure of the implant. It is approximately 2 to 10 microns in thickness and overlays

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the calcium carbonate substructure. Once implanted, the calcium phosphate outer laver will slowly resorb, delaving exposure of the underlying and faster resorbing calcium carbonate. Calcium carbonate resorption will normally occur within six months or less.

When Pro Osteon 500R 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 Pro Osteon 500R 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 implant.

# INDICATIONS FOR USE

Pro Osteon 500R Resorbable Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Pro Osteon 500R 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 void filler that resorbs and is replaced with bone during the healing process.

# COMPARISON TO THE PREDICATE DEVICE

Pro Osteon 500R is technologically very similar to the predicate device with the following exceptions:

- Pro Osteon 500R is a composite material of calcium carbonate and 1. calcium phosphate. The predicate device is composed of calcium sulfate.
- Pro Osteon 500R has a resorption rate of 6 months or less versus 2. Osteoset's 30 to 60 days.
- Pro Osteon 500R provides an interconnected, porous scaffold which 3. supports new bone ingrowth, while the predicate device is non-porous and is quickly resorbed in vivo.

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# CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND COMPLI-CATIONS

- 1. Contraindications
Pro Osteon 500R 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.

- 2. Warnings and Precautions
Pro Osteon 500R 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 500R Resorbable Bone Void Filler is intended for use by surgeons familiar with bone grafting and rigid fixation techniques. Complete postoperative wound closure is essential.

Pro Osteon 500R is radiopaque until resorbed. Radiopacity may mask underlying pathological conditions. Radiopacity may also make it difficult to radiographically assess the ingrowth of new bone.

- 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.

### TESTING SUMMARY

Animal testing demonstrates bone formation rate and resorption of Pro Osteon 500R is substantially equivalent to the predicate device for the repair of tibial defects in rabbits. Dissolution studies demonstrate that Pro Osteon 500R has dissolution rates which are similar to the predicate device when

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compared to essentially non-resorbable bone graft substitute materials. Mechanical testing demonstrates that Pro Osteon 500R has compressive characteristics substantially equivalent to the predicate device and to trabecular bone. Testing indicates the product to be non-pyrogenic and nontoxic. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The product design, material of construction, and function as a bone void filler are substantially equivalent to the FDA cleared and legally marketed predicate device.

- Pro Osteon 500R and the predicate device are both calcium salts. Pro 1. Osteon 500R is a composite of calcium carbonate and calcium phosphate. Osteoset is composed of calcium sulfate and stearic acid.
- 2. Pro Osteon 500R and the predicate device are resorbed following implantation.
- 3. Pro Osteon 500R and the predicate device provide an environment for new bone ingrowth.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David P. Balding ·Interpore International 181 Technology Drive Irvine, California 92618-2402

SEP 2 5 1998 Re: K980817 Pro Osteon® Resorbable Bone Void Filler Requlatory Class: Unclassified Product Code: MQV June 30, 1998 Dated: Received: July 1, 1998

Dear Mr. Balding:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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.

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#### Page 2 - Mr. David P. Balding

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K980817

Device Name: Pro Osteon® 500R Resorbable Bone Void Filler

#### Indications for Use:

Pro Osteon® 500R Resorbable Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Pro Osteon 500R 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 void filler that resorbs and is replaced with bone during the healing process.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K980817

Prescription Use
(PER 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)