OSTEOPORE PCL SCAFFOLD

K051093 · Osteopore, Inc. · GXP · Mar 17, 2006 · Neurology

Device Facts

• Record ID: K051093
• Device Name: OSTEOPORE PCL SCAFFOLD
• Applicant: Osteopore, Inc.
• Product Code: GXP · Neurology
• Decision Date: Mar 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteopore PCL Scaffold™ Bone Filler is intended for use in the repair of neurosurgical burr holes, ria otwopore FOL boareer anial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton. It should be gently packed into bony voids or gaps of the skeletal system.

Device Story

Osteopore PCL Scaffold is a bone void filler designed to repair cranial defects and restore craniofacial bony contours. Device conforms to defect shape to maximize contact with viable host bone. Material is polycaprolactone (PCL). Clinician packs scaffold into bony voids or gaps. Device acts as a scaffold for bone growth. Benefits include structural support for bone healing in neurosurgical and craniofacial applications.

Clinical Evidence

Performance evaluated using a rabbit calvarial defect model. No human clinical data provided.

Technological Characteristics

Bone void filler composed of polycaprolactone (PCL). Scaffold design conforms to defect geometry. Biocompatibility profile equivalent to FDA-cleared absorbable suture materials.

Indications for Use

Indicated for repair of neurosurgical burr holes, craniotomy cuts, and other cranial defects; augmentation or restoration of bony contour in the craniofacial skeleton.

Regulatory Classification

Identification

Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

Predicate Devices

• PCL Monofilament Surgical Specialties Absorbable Suture (K003015)
• WMT-TCP (K022629)
• ChronOS (K013072)
• Ethicon's Monocryl (Poliglecaprone 25) (K930772)
• E caprolactone/Glycolide (K013671)
• U.S. Surgical's Caprosyn (Polyglytone 6211) (K032307)

Submission Summary (Full Text)

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### 510 K SUMMARY (K051093)

| Proprietary Name: | Osteopore PCL Scaffold Bone Void Filler (BVF) | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Common Name: | Bone Filler | |
| Classification Name: | GXP | |
| Predicate Device/Material | PCL Monofilament Surgical Specialties<br>Absorbable Suture<br>WMT-TCP<br>ChronOS<br>Ethicon's Monocryl(Poliglecaprone 25)<br>E caprolactone/Glycolide 510 (k)<br>U.S. Surgical's Caprosyn<br>(Polyglytone 6211)<br>Glycolide, caprolactone.trimethylene<br>carbocarbonate and lactide 510 (k)<br>CAP BONE SUBSTITUTE MATERIAL | K003015<br>K022629<br>K013072<br>K930772<br>K013671<br>K032307 |
| Device Sponsor: | Osteopore Inc<br>958 Kristin Ridge Way<br>Milpitas CA 95035 | |
| Manufacturer: | Osteopore International Pte Ltd<br>10 Science Park II<br>#02-28 The Alpha<br>Singapore 117684 | |
| Official Correspondent: | Alexander Yeo | |

#### Device Description:

The Osteopore PCL Scaffold™ is a bone void filler. The Shape of the Osteopore PCL Scaffold™ conforms to the defect, thus maximizing direct contact with viable host bone.

### Intended Use:

The Osteopore PCL Scaffold™ Bone Filler is intended for use in the repair of neurosurgical burr holes, ria otwopore FOL boareer anial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton. It should be gently packed into bony voids or gaps of the skeletal system.

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#### Evaluation of Device

Osteopore PCL Scaffold'™ was evaluated for performance using a rabbit calvarial defect model. The Ostoppic I CL Bourold --------------------------------------------------------------------------------------------------------------------------------------------------------

#### Summary of substantial equivalence

The Osteopore PCL Scaffold™ shares indications and design principles with the following predicate The Osteopore I CL Scarrold Specialtis (K003015) and Absorbable Suture WMT-TCP devices, PCL Monomancil by the FDA to be substantially equivalent to pre-amendment (RUZ2029), Willch have been decemined by the same material biocompatibility, cytotoxicity, devices. The Oscopore FCD Dearera - exard carcinogenicity as FDA cleared suture products. genotoxicity, "Stistization," turnity" and "carent","and" our seating which are equivalent to FDA cleared suture devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in capital letters.

Public Health Service

MAR 1 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Alexander Yeo Osteopore, Inc. 958 Kristin Ridge Way Milpitas, CA 95035

Re: K051093

Trade/Device Name: Oseopore PCL Scaffold Bone Void Filler Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: Class II Product Code: GXP Dated: December 15, 2005 Received: December 19, 2006

Dear Mr. Yeo:

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

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## Page 2 – Mr. Alexander Yeo

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as Sectionic 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 This letter will anow you to beginning of substantial equivalence of your device 510(x) premarket nothreation:- 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), If you desire specific at Compliance at [phone]. Also, please note the regulation predace concerner of over by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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,

Sincerely yours,

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# osteopore

958 Kristin Ridge Way Milpitas CA 95035

### INDICATIONS FOR USE

-510(K) Number K051093:

Osteopore PCL Scaffold™ Bone Void Filler Device Name:

Indications for Use:

The Osteopore PCL Scaffold™ Bone Filler is intended for the use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (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.)

Herbert Lemons Jr

(Division Sign-Off Division of General, Restorative, and Neurological Devices

Kos 1093 510(k) Number