(240 days)
GranOS™ devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GranOS™ is indicated to be gently placed into bony voids or gaps of the skeletal system (ie the extremities, posterolateral spine and pelvis). These defects may be surgically created 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.
GranOS™ is a porous, resorbable osteoconductive scaffold constructed of highly pure beta tricalcium phosphate granules for use in the repair of bony defects.
This document is a 510(k) Premarket Notification for a medical device called GranOS™ - beta tricalcium phosphate synthetic bone granules. It establishes substantial equivalence to legally marketed predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of diagnostic or prognostic performance. The information provided does not describe a clinical study in the typical sense of measuring diagnostic accuracy or treatment effectiveness with human subjects.
Therefore, the requested information elements related to diagnostic performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment for a diagnostic AI device are not applicable to this document. This document focuses on the technical and safety characteristics for regulatory approval as a bone void filler.
However, I can extract the relevant information from the document regarding the device's technical characteristics and how it meets regulatory standards for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like bone void fillers, "acceptance criteria" are typically defined by recognized standards and comparison to predicate devices, focusing on material properties, biocompatibility, and intended use. The performance is then demonstrated through non-clinical testing to meet these standards and show equivalence to predicates.
| Acceptance Criteria / Characteristic Type | Specific Criteria / Predicate Values | Reported Device Performance (GranOS™) |
|---|---|---|
| Chemical Composition | Beta tricalcium phosphate Ca3(PO4)2 meeting ASTM F 1088-04a (2010) | Beta tricalcium phosphate Ca3(PO4)2 meeting ASTM F 1088-04a (2010), same as predicates |
| Patient Population | Individuals with bony defects resulting from surgery or trauma | Individuals with bony defects resulting from surgery or trauma, same as predicates |
| Anatomical Locations | Bony voids/gaps in extremities, posterolateral spine, and pelvis | To be packed into irregular shaped bony voids of the skeletal system (extremities, spine, pelvis), same as predicates |
| Physical Structure | Interconnected porosity (most predicates) / Trabecular structure (one predicate) | Interconnected porosity |
| Porosity | Approximately 70% (two predicates) / 60-70% (one predicate) / 90% (one predicate) | Approximately 70% |
| Pore Size | Micropores <1 - 700μm (one predicate) / >0-<80 μm (one predicate) / 1-1000 μm | Micropores <1 - 700μm |
| Osteoconductivity | Osteoconductive | Osteoconductive |
| Sterility | Sterilised by Gamma Radiation, SAL of 1 x 10^-6 | Sterilised by Gamma Radiation, single use only, Sterility Assurance Level (SAL) of 1 x 10^-6, same as predicates |
| Biocompatibility | Established (for all predicates) | Established |
| Presentation (Granule Sizes) | Varies among predicates (e.g., 250-500μm, 1-2.8mm, 2-4mm, 500-1000μm, 1-4mm morsels) | Granule Sizes: 250-500μm, 1-2.8mm, 2-4mm (matches one predicate exactly, similar ranges to others) |
| Critical Specifications | Chemistry, crystallinity, physical form, porosity, dissolution/solubility | GranOS™ demonstrated to have the same critical specifications as the predicate device through non-clinical performance tests. |
| Regulatory Guidance Adherence | Meet "The Class II Special Controls Guidance: Document Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA" | Key requirements and recommendations met within the specified Class II Special Controls Guidance. |
| Contraindications, Instructions, Warnings, Precautions, Adverse Reactions | Same as predicate devices to avoid new questions regarding safety and effectiveness | GranOS™ has the same Contraindications, Instructions, Warnings, Precautions, and possible adverse reactions/complications when directly compared to the predicate devices. |
Study Proving Device Meets Acceptance Criteria:
The document describes non-clinical testing as the primary study type to demonstrate that GranOS™ meets acceptance criteria and is substantially equivalent to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
This is not applicable as this is a non-clinical submission. The "test set" here refers to the physical samples of the GranOS™ material itself that underwent laboratory testing. The document does not specify a numerical sample size for these material tests, nor does it refer to data provenance in terms of country of origin or retrospective/prospective studies. Such details would typically be found in the full test reports, not summarized in the 510(k).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This is not applicable. The "ground truth" for material properties is established through validated laboratory testing methods per recognized standards (e.g., ASTM F1088-04a). Expert review would be part of the quality system and regulatory submission process, but not in the sense of adjudicating diagnostic findings.
4. Adjudication Method for the Test Set:
Not applicable for non-clinical material testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a biomaterial, not a diagnostic imaging AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a biomaterial, so there is no algorithm or AI component.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance is established by technical specifications and recognized performance standards (e.g., ASTM F1088-04a for beta tricalcium phosphate for Surgical Implantation) and direct comparison to legally marketed predicate devices in terms of material characteristics, intended use, and safety profile.
8. Sample Size for the Training Set:
Not applicable. There is no AI or algorithm involved, and thus no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2015
TCM Associates Ltd Mr. Iain Alligan Technical Director 3 Hillgrove Business Park Nazeing Road Essex EN9 2HB United Kingdom
Re: K143692
Trade/Device Name: GranOS - beta tricalcium phosphate synthetic bone granules Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: July 13, 2015 Received: July 23, 2015
Dear Mr. Alligan:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K143692
Device Name
GranOSTM - beta tricalcium phosphate synthetic bone granules
Indications for Use (Describe)
GranOS™ devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GranOS™ is indicated to be gently placed into bony voids or gaps of the skeletal system (ie the extremities, posterolateral spine and pelvis). These defects may be surgically created 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Section 5
Premarket Notification 510(k) Summary
beta tricalcium phosphate synthetic bone granules (Trade Name: GranOS™)
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5.1 Premarket Notification 510(k) Summary
GranOS™ - beta tricalcium phosphate synthetic bone granules
(per 21 CFR 807.92)
| Submitter (Owner) | TCM Associates Ltd3 Hillgrove Business ParkNazeing RoadNazeingEssexEN9 2HBUnited Kingdom |
|---|---|
| Contact Person | Iain Alligan, Technical DirectorPhone: +44 (0) 1992 892 085Fax: +44 (0) 1992 893 721 |
| Date prepared | 20th August 2015 |
| Trade Name | GranOS™ - beta tricalcium phosphate synthetic bone granules |
| Common Name | Synthetic bone void filler |
| Device Classification | Resorbable calcium salt bone void filler device |
| Regulation | Class II Special Controls as per 21 CFR 888.3045 |
| Device Product Code | MQV |
| Legally MarketedPredicate Devices | βGran® Synthetic Osteoconductive Scaffold (K041616)Cerasorb® ORTHO (K014156)Vitoss® Scaffold Synthetic Cancellous Bone Void Filler K032409 |
| Device Description | GranOS™ is a porous, resorbable osteoconductive scaffold constructed of highly purebeta tricalcium phosphate granules for use in the repair of bony defects. |
| Intended Use | GranOS™ devices are indicated only for bony voids or gaps that are not intrinsic to the stability of thebony structure. GranOS™ is indicated to be gently placed into bony voids or gaps of the skeletalsystem (i.e. the extremities, posterolateral spine, and pelvis). These defects may be surgically createdosseous defects or osseous defects created from traumatic injury to the bone. The product providesbone void filler that resorbs and is replaced with bone during the healing process |
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| 510k (Traditional) Premarket Submission | TCM Associates Ltd | ||
|---|---|---|---|
| Device: | GranOS™ - beta tricalcium phosphate synthetic bone granules | Issue: | 03 |
| Classification: | Resorbable calcium salt bone void filler device | Issue Date: | 20.08.2015 |
| Page Title: | Section 5: Premarket Notification 510(k) Summary |
| Technological Characteristics - Comparison to Predicates and Substantial Equivalence | |
|---|---|
| Trade Name | GranOS™ - betatricalcium phosphatesynthetic bone granules | βGran® syntheticosteoconductive scaffold | Cerasorb® ORTHO | Vitoss® ScaffoldSynthetic CancellousBone void Filler |
|---|---|---|---|---|
| 510(k)Registration No: | K143692 | K041616 | K014156 | K032409 |
| Chemicalcomposition of thematerial | beta tricalcium phosphateCa3(PO4)2 meeting therequirements ofASTM F 1088-04a (2010) | beta tricalcium phosphateCa3(PO4)2 meeting therequirements ofASTM F 1088-04a (2010) | beta tricalcium phosphateCa3(PO4)2 meeting therequirements of ASTM F1088-04a (2010) | beta tricalcium phosphateCa3(PO4)2 meeting therequirements ofASTM F 1088-04a (2010) |
| Patient Population | Individuals with bonydefects resulting fromsurgery or trauma | Individuals with bony defectsresulting from surgery ortrauma | Patients with bone voidsor gaps caused by surgerytrauma or degeneration | Individuals with bonydefects resulting fromsurgery or trauma |
| AnatomicalLocations | To be packed into theirregular shaped bony voidsof the skeletal system i.e.extremities, spine and pelvis | Bony voids or gaps of theskeletal system i.e. theextremities, spine and pelvis | Skeletal systemextremities, spine andpelvis | Bony voids or gaps of theskeletal system i.e. theextremities, spine andpelvis |
| Physical Structureof the Material | Interconnected porosity | Interconnected porosity | Interconnected porosity | Trabecular structuresimilar to cancellousbone |
| Porosity | Approximately 70% | Approximately 70% | Approximately 60% - 70% | Approximately 90% |
| Pore Size (range) | Micropores <1 - 700μm | Micropores <1 - 700μm | Micropores >0<80 μm | 1-1000 μm |
| Performance | ||||
| Osteoconductivity | Osteoconductive | Osteoconductive | Osteoconductive | Osteoconductive |
| Sterility | Sterilised by GammaRadiation, single use only.Sterility Assurance Level(SAL) of 1 x 10-6 | Sterilised by GammaRadiation, single use only.Sterility Assurance Level(SAL) of 1 x 10-6 | Sterilised by GammaRadiation, single use only.Sterility Assurance Level(SAL) of 1 x 10-6 | Sterilised by GammaRadiation, single useonly. Sterility AssuranceLevel (SAL) of 1 x 10-6 |
| Biocompatibility | Established | Established | Established | Established |
| Presentation | Granule Sizes250-500μm1 – 2.8mm2 – 4mm | Granule Sizes250-500μm1 – 2.8mm2 – 4mm | Granules and Blocks500 - 1000μm1000 - 2000μm | Morsels 1-4mm andcylinders 9 x 23mm |
Results of non-clinical performance tests has demonstrated that GranOS™ - beta tricalcium phosphate granules have the same critical specification (i.e. chemistry, crystallinity, physical form, porosity, dissolution/solubility) and the same intended use as the predicate device.
Key requirements and recommendations have also been met within The Class II Special Controls Guidance: Document Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.
Non-clinical testing
GranOS™ - beta tricalcium phosphate granules have been tested and shown to be in compliance to the following recognised performance standard: ASTM F1088-04a 2010 - Standard Specification for beta tricalcium phosphate for Surgical Implantation. In addition, GranOS™ - beta tricalcium phosphate granules have the same Contraindications, Instructions, Warnings, Precautions and possible adverse reactions/complications when directly compared to the predicate devices and so does not raise new questions regarding safety and effectiveness and therefore substantial equivalence is claimed under Section 513(i) of the FD&C Act (21 U.S.C. § 360c(i)).
[21CFR 807.92(b)(1) and 21CFR 807.92(b)(2])
Conclusion
Based on the results of the non-clinical testing and the clinical evaluation of the product, we conclude that GranOS™ - beta tricalcium phosphate granules are as safe, as effective, and performs as well as or better than the predicate device.
[21CFR 807.92(b)(3)
§ 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.