The INION BIORESTORE™ implants are bone graft substitutes indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. INION BIORESTORE™ 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 Description

Inion BioRestore™ is an osteoconductive and osteostimulative bioactive bone graft device. In vivo tests have demonstrated more bone formation at each post-implantation timepoint and more total bone formation compared to other osteoconductive devices such as hydroxyapatite. In vitro cell culture tests with human adipose mesenchymal stem cells have demonstrated an osteostimulative effect, defined as the active stimulation of osteoblast proliferation and differentiation as evidenced by alkaline phosphatase activity. This stimulation has been attributed as being the result of the interaction between osteoblasts and the ionic dissolution products released from Inion BioRestore™ during its absorption. Clinical data on humans on rate and extent of bone formation observed in cell culture and animal models has not been established.

Bioactive materials are those materials that elicit a specific biological response at the interface of the material that results in the formation of a bond between the tissues and the material. Osteostimulation is a "... property of some bioactive materials to enhance, actively stimulate both the proliferation and differentiation of progenitor cells (e.g. mesenchymal stem cells) ... "1.2

Inion BioRestore™ system consists of different size cylinders, blocks and morsels made of degradable bioactive glass. When implanted, a kinetic modification of the surface occurs, resulting in the formation of a calcium phosphate layer that is essentially similar in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow allowing complete repair of the defect. Based on pre-clinical testing, most of the material degrades in vivo in six months. The material is radiopaque. Inion BioRestore™ implants are intended for single use and are provided sterile to the user. They are completely synthetic and noncollagenous.

AI/ML Overview

This 510(k) summary for Inion BioRestore™ describes a medical device clearance based on substantial equivalence to predicate devices, rather than a study against a pre-defined set of acceptance criteria with detailed performance metrics. Therefore, several requested categories of information directly related to performance studies with acceptance criteria, ground truth, and expert evaluation are not applicable or not provided in this document.

Here's a breakdown of the requested information based on the provided text:

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
Not explicitly stated as numerical performance criteria.	The device is deemed "substantially equivalent" to predicate devices.	The 510(k) summary focuses on demonstrating that Inion BioRestore™ is as safe and effective as legally marketed predicate devices, not on meeting specific, pre-defined numerical performance targets.
Osteoconductivity	Demonstrated in vivo tests showing "more bone formation at each post-implantation timepoint and more total bone formation compared to other osteoconductive devices such as hydroxyapatite."	This is a comparative claim, not against an acceptance criterion. No specific numerical thresholds are provided.
Osteostimulation	Demonstrated in vitro cell culture tests with human adipose mesenchymal stem cells showing "an osteostimulative effect, defined as the active stimulation of osteoblast proliferation and differentiation as evidenced by alkaline phosphatase activity."	This is a qualitative claim based on in vitro testing. No specific numerical thresholds or comparative data against an acceptance criterion are provided.
Degradation	Based on pre-clinical testing, "most of the material degrades in vivo in six months."	This is an estimated timeframe based on pre-clinical data, not an explicit acceptance criterion against which performance is numerically measured.
Radiopacity	"The material is radiopaque."	This is a qualitative characteristic, not a performance metric against a specific criterion.

Study Information

Sample size used for the test set and the data provenance:
- Test set and data provenance specific to a performance study: Not explicitly stated. The document refers to "in vivo tests" and "in vitro cell culture tests," but does not provide details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature) for these tests in the context of a "test set" for regulatory evaluation against acceptance criteria.
- The "performance data and specifications" mentioned in the substantial equivalence statement are used to compare the device to predicates, not against a standalone test set for specific acceptance criteria.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no specific "test set" requiring expert ground truth establishment for regulatory acceptance is detailed in this 510(k) summary. The evaluation relies on comparison to predicate devices and general pre-clinical testing results.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no specific "test set" with a need for expert adjudication is detailed.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a bone graft substitute, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical bone graft substitute, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "in vivo tests" demonstrating bone formation: The "ground truth" would likely be based on histological analysis, imaging (e.g., radiography, micro-CT) for assessing bone growth, and potentially gross examination by animal pathologists or histology experts. However, specific details are not provided.
- For the "in vitro cell culture tests": The "ground truth" for osteostimulation is evidenced by "alkaline phosphatase activity," which is a biochemical marker for osteoblast differentiation.
The sample size for the training set:
- Not applicable. This device is a physical bone graft substitute, not an AI model that requires a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.

In summary, this 510(k) clearance is based on demonstrating "substantial equivalence" to existing predicate devices, leveraging pre-clinical (in vivo and in vitro) data for general characterization rather than a specific performance study against defined acceptance criteria with a detailed clinical test set and expert evaluation. The document confirms that there are "no applicable mandatory performance standards" for this device.

Summary

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510(k) SUMMARY

Inion BioRestore™

0CT 1 1 2007

Manufacturer and submitter

Inion Oy, Lääkärinkatu 2, FIN-33520 Tampere, FINLAND

Contact Person

Kati Marttinen, Regulatory Affairs Specialist Phone: +358 10 830 6600 Fax: +358 10 830 6691 kati.marttınen@inion.com

Establishment registration number

9710629

Trade name of the device Inion BioRestore™

Device classification and product code

Class II (Special controls) Classification Panel: Orthopedic Product Code: MQV Common name: Osteoconductive and osteostimulative bone void filler; Synthetic resorbable bone graft material Regulation number: 888.3045

Predicate devices

NovaBone ® (K000149) NovaBone ® Resorbable Bone Graft Substitute (K021336) NovaBone ® Porous Bone Graft Scaffold (K060432) NovaBone ® Resorbable bone graft substitute (K052494) PerioGlass ® Bioglass ® Bone Graft Particulate (K040278)

Conformance with performance standards

No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application.

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510(k) SUMMARY

Inion BioRestore™

Device description and principles of operation

Indications for use

The Inion BioRestore™ implants are bone graft substitutes indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Inion BioRestore™ 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.

1 Society for Biomaterials presentation, 24th Annual Meeting, 1998:511-518

2 J Appl Biomat 1992, 3:123-129

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510(k) SUMMARY

Inion BioRestore™

Substantial equivalence to marketed products

Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, degradation properties, bioactive, osteoconductive and osteostimulative properties of Inion BioRestore™ implants are substantially equivalent with the predicate Class II devices, when used in the indications for use described above, because the differences between Inion BioRestore™ and the predicate devices do not raise new questions of safety and effectiveness.

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Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, clutching a staff with a snake wrapped around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 1 2007

Inion Oy % Ms. Kati Marttinen Regulatory Affairs Specialist Lääkärinkatu 2 33520Tampere, Finland

Re: K070998 Trade/Device Name: BioRestore™ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: Class II Product Code: MQV Dated: August 6, 2007 Received: August 9, 2007

Dear Ms. Marttinen:

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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Kati Marttinen

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sarbay Buehum

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

Enclosure

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Statement of Indications for Use

510(k) Number:

K070998

Device Name:

Inion BioRestore™

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 OF NEEDED)

currence of CDRH, Office of Device Evaluation (ODE)

Arbera Knerp

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K070998

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
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.(b)
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.