Osteo-P Bone Graft Substitute

K170165 · Molecular Matrix, Inc. · MQV · Dec 29, 2017 · Orthopedic

Device Facts

• Record ID: K170165
• Device Name: Osteo-P Bone Graft Substitute
• Applicant: Molecular Matrix, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Dec 29, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Osteo-PTM Bone Graft Substitute is indicated for use only in the treatment of bony voids or gaps that are not intrinsic to the stability of the bony structure. It is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis), and the opening to the defect site sealed with bone wax. These defects may be surgically created osseous defects or osseous defects created from traumatic or degenerative injury to the bone. Subsequent to implantation, Osteo-PTM Bone Graft Substitute is resorbed and replaced with bone during the healing process.

Device Story

Osteo-PTM is a radiolucent, porous, osteoconductive polymeric carbohydrate bone void filler; trabecular structure mimics human cancellous bone. Device provided sterile in various forms (granules, sheets, cubes, wedges, cylinders). Surgeon manually packs material into bony voids or gaps; defect site opening sealed with bone wax. Device supports/guides new bone ingrowth; resorbed during healing. Used in clinical settings for orthopedic/trauma procedures. Benefits patient by providing scaffold for bone regeneration in non-load-bearing defects.

Clinical Evidence

No human clinical data. Evidence based on bench testing and animal study. NZW Rabbit femoral condyle critical-sized defect study compared Osteo-PTM to predicate and autograft, demonstrating new bone formation consistent with FDA requirements for Class II Bone Void Fillers. Extensive in vitro and in vivo biocompatibility testing performed.

Technological Characteristics

Porous osteoconductive polymeric carbohydrate matrix; radiolucent. Porosity 75-95%; pore size ~1-700 µm. Non-pyrogenic. Sterile (SAL 10^-6) via E-Beam. Supplied in various preformed shapes (granules, sheets, cubes, wedges, cylinders). Does not impart mechanical strength.

Indications for Use

Indicated for treatment of bony voids or gaps not intrinsic to skeletal stability in extremities and pelvis. Applicable to surgically created osseous defects or those resulting from traumatic or degenerative injury.

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

• InQu® (K063359)

Reference Devices

• chronOS® (K013072)

Submission Summary (Full Text)

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December 29, 2017

Molecular Matrix, Inc. % Mr. John Kapitan Chief Executive Officer Kapstone Medical P.O. Box 969 Leicester, North Carolina 28748

Re: K170165

Trade/Device Name: Osteo-PTM Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: November 27, 2017 Received: November 30, 2017

Dear Mr. Kapitan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K170165

Device Name Osteo-PTM Bone Graft Substitute

#### Indications for Use (Describe)

Osteo-PIM Bone Graft Substitute is indicated for use only in the treatment of bony voids or gaps that are not intrinsic to the stability of the bony structure. It is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis), and the opening to the defect site sealed with bone wax. These defects may be surgically created osseous defects or osseous defects created from traumatic or degenerative injury to the bone. Subsequent to implantation, Osteo-PTM Bone Graft Substitute is resorbed and replaced with bone during the healing process.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

Image /page/3/Picture/3 description: The image shows the logo for Molecular Matrix. The logo consists of a stylized "M" formed by interconnected blue spheres, followed by the text "Molecular Matrix" in blue font. The word "Matrix" has a trademark symbol next to it.

In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) summary for Osteo-P™ is provided below.

| Date Summary Prepared: | November 17, 2017 |
|-----------------------------------------------------------------|-------------------------------------------------------------------------|
| Submitter Name: | Molecular Matrix, Inc. |
| Submitter Address: | 3410 Industrial Blvd., Suite 103<br>West Sacramento, CA. 95691 |
| Contact Person: | John Kapitan<br>Kapstone Medical, LLC |
| Phone Number:<br>Fax Number: | 916-374-9404<br>530-231-6126 |
| Device Trade Name: | Osteo-PTM Bone Graft Substitute |
| Device Common Name: | Resorbable bone void filler |
| Classification Name:<br>Classification Number:<br>Product Code: | Bone Void Filler Device<br>21 CFR 888.3045<br>MQV |
| Primary Predicate Device:<br>Reference Device: | K063359 ISTO Technologies, Inc. InQu®<br>K043045 Synthes (USA) chronOS® |

### Device Description

Osteo-PTM Bone Graft Substitute is a radiolucent bone void filler composed of a porous, osteoconductive polymeric carbohydrate with a trabecular structure simulating the multidimensional interconnectivity of human cancellous bone. When placed in direct contact with host bone, Osteo-PTM supports and guides the ingrowth of new bone across the graft site and is resorbed as the healing process occurs. The consistency of Osteo-P™ allows the surgeon to easily manipulate and maximize the direct contact with viable host bone. It is intended for single patient use only and is provided sterile in single-use double sterile packaging. Osteo-P™ is available in various forms to include granules, sheets, cubes, wedges, and cylinders.

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## Indications for Use

Osteo-PTM Bone Graft Substitute is indicated for use only in the treatment of bony voids or gaps that are not intrinsic to the stability of the bony structure. It is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis), and the opening to the defect site sealed with bone wax. These defects may be surgically created osseous defects or osseous defects created from traumatic or degenerative injury to the bone. Subsequent to implantation. Osteo-PTM Bone Graft Substitute is resorbed and replaced with bone during the healing process.

## Technological Characteristics

Testing has confirmed Osteo-P™ Bone Graft Substitute to be biocompatible as a bone void filler device. Animal testing demonstrated evidence of new bone formation consistent with FDA's recommendations for performance testing of Class II Bone Void Filler Devices. Osteo-P™ is substantially equivalent to the predicate device in terms of design, function, intended use and bone healing performance in an animal model. Results from a NZW Rabbit femoral condyle critical-sized defect study comparing Osteo-P™ to the predicate device and autograft as well as extensive biocompatibility testing demonstrated that the differences in raw material composition do not raise new issues of safety and effectiveness.

| Characteristic | Osteo-PTM Bone Graft<br>Substitute<br>(subject device) | InQu® Bone Graft<br>Substitute<br>(predicate device) | chronOS® Bone Void<br>Filler<br>(reference device) | Comparison |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| 510(k) | | K063359 | K013072 | N/A |
| Intended Use | Resorbable Bone void<br>Filler | Resorbable Bone void<br>Filler | Resorbable Bone void<br>Filler | Equivalent |
| Target Population | Individuals with bony<br>defects resulting from<br>surgery or trauma; not<br>intrinsic to the stability of<br>the structure | Individuals with bony<br>defects resulting from<br>surgery or trauma; not<br>intrinsic to the stability of<br>the structure | Individuals with bony<br>defects resulting from<br>surgery or trauma; not<br>intrinsic to the stability of<br>the structure | Equivalent |
| Anatomical<br>Location | Bony voids or gaps of the<br>skeletal system, (i.e., the<br>extremities and pelvis) | Bony voids or gaps of the<br>skeletal system, (i.e., the<br>extremities and pelvis) | Bony voids or gaps of the<br>skeletal system, (i.e., the<br>extremities, spine and<br>pelvis) | Equivalent to<br>predicate<br>device |
| Technological<br>Characteristics | | | | |
| Principle of<br>Operation | Provide Osteoconductive<br>Matrix | Provide Osteoconductive<br>Matrix | Provide Osteoconductive<br>Matrix | Equivalent |
| Material of<br>Construction | Porous osteoconductive<br>polymer matrix | Porous osteoconductive<br>polymer matrix | Porous osteoconductive<br>polymer matrix | Equivalent |
| Shapes | Variety (to include):<br>Granules, Sheets, Cubes,<br>Wedges, and Cylinders | Variety: Granules and<br>Sheets | Variety (to include):<br>Granules, Blocks, Wedges,<br>and Cylinders | Equivalent to<br>reference<br>device |
| Sizes | Granules: 1-5mm<br>Preformed shapes: Variety | Granules: 2-5mm<br>Sheets: Variety | Granules: 1.4mm-2.8mm &<br>2.8mm-5.6mm.<br>Preformed shapes: Variety | Equivalent |

## Substantial Equivalence

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| Molecular Matrix, Inc. | | | | Traditional 510(k) |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------|
| Porosity | 75-95% | 75-90% | 60-70% | Equivalent to<br>predicate<br>device |
| Pore Size | ~1-700 µm<br>main distribution: 50-500<br>µm | ~1-300µm | Macropores: 100-500µm<br>(main distribution)<br>Micropores: <10 µm | Equivalent |
| Radiolucency | Radiolucent | Radiolucent | Radiopaque | Equivalent to<br>predicate<br>device |
| Performance | | | | |
| Surgical<br>Application<br>Restrictions/Use | Gently packed into defect.<br>Requires appropriate<br>fixation/stabilization.<br>Requires hydration | Gently packed into defect.<br>Requires appropriate<br>fixation/stabilization.<br>Requires hydration. | Gently packed into defect.<br>Requires appropriate<br>fixation/stabilization.<br>Requires hydration | Equivalent |
| Osteoconductivity | Osteoconductive | Osteoconductive | Osteoconductive | Equivalent |
| Resorbable | Yes | Yes | Yes | Equivalent |
| Mechanical<br>Strength | Does not impart mechanical<br>strength to surgical site. | Does not impart mechanical<br>strength to surgical site. | Compressive strength<br>~5MPa | Equivalent to<br>predicate<br>device |
| Packaging | Double sterile pack. | Double sterile pack | Double sterile pack. | Equivalent |
| Sterility | Sterile, SAL 10-6 | Sterile, SAL 10-6 | Sterile, SAL 10-6 | Equivalent |
| Sterilization<br>Method | E-Beam | E-Beam | E-Beam | Equivalent |
| Pyrogenicity | Non-pyrogenic<br>Limulus Amebocyte Lysate<br>(LAL) Chromogenic<br>Endotoxin Quantitation<br>Assay | Non-pyrogenic | Non-pyrogenic | Equivalent |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Equivalent |

The following technological differences exist between the subject and predicate or reference devices:

| Characteristic | Osteo-PTM | InQu® | chronOS® |
|----------------------|-----------------------------------------------------|-------------------------|----------------------------------------|
| | (subject device) | (predicate device) | (reference device) |
| Material Composition | Porous Hyper Cross-linked<br>Polymeric Carbohydrate | Porous PGLA / HA matrix | Porous β-Tricalcium<br>Phosphate (TCP) |

Pre-Clinical Testing confirmed that despite differences in material composition, Osteo-P™ is equivalent to the predicate device in function, indication for use, device classification product code, environment of use, and principles of operation to the predicate device. The biocompatibility of Osteo-P™ has also been confirmed through extensive in vitro and in vivo testing.