NanOss™ is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (i.e., extremities, posterolateral spine, and pelvis). NanOss must be mixed with autogenous blood or sterile saline for use in the extremities or pelvis. NanOss must be mixed with bone marrow aspirate and autograft bone as a bone graft extender in the posterolateral spine. These defects may be surgically created osseous defects or 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

NanOss™ is a resorbable bone void filler (BVF) consisting of calcium phosphate and a porcine gelatin carrier provided in granular form. The BVF is radiopaque, provided sterile and is intended for single use only. The product is provided pre-filled in a mixing container as NanOss™ or in a mixing chamber/syringe as NanOss™ Loaded.

The purpose of this submission is to obtain clearance for a merged indications for use statement and new packaging configuration (NanOssTM Loaded Kit). In addition, instrument accessories previously cleared for MIS graft placement in the posterolateral spine through a small incision are now available for graft placement in the skeletal system (i.e., extremities, pelvis).

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called NanOss™, NanOss™ Loaded, and NanOss™ Loaded Kit. It is a resorbable calcium salt bone void filler device.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the device is cleared based on demonstrating "substantial equivalence" to predicate devices, rather than meeting specific quantifiable performance acceptance criteria in clinical studies. The "testing" section lists non-clinical tests.

Acceptance Criteria Category	Specific Acceptance Criteria (Not Explicitly Stated as Numerical)	Reported Device Performance (Summary from Submission)
Substantial Equivalence	The device should have the same intended uses, operating principles, basic design, and materials as legally marketed predicate devices.	The bone void filler has the following similarities to the previously cleared bone void filler product (K110561/K100361): - Same intended uses - Same operating principles - Same basic design - Same materials - Provided sterile and for single-use.
Packaging & Shelf-Life	Validated according to ASTM D4169-09: DC 13 & 17 and ASTM F1980.	Non-clinical tests were performed to support substantial equivalence.
Sterilization	Validated according to ISO 11137-1.	Non-clinical tests were performed to support substantial equivalence.
Instrument Validation	Validated for instrument accessories.	Non-clinical tests were performed to support substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical study with a "test set" in the context of device performance metrics (e.g., sensitivity, specificity for an AI device). The non-clinical tests mentioned do not specify sample sizes or data provenance in the way a clinical trial would. This submission is for a bone void filler, which typically undergoes biocompatibility, mechanical, and degradation testing, but these details (including sample sizes and provenance) are not provided in this summary. The "testing" section lists only non-clinical tests (packaging, shelf-life, sterilization, instrument validation).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study involving expert assessment to establish ground truth (e.g., for image interpretation).

4. Adjudication Method for the Test Set

Not applicable.

5. 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 is not an AI/software device undergoing an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device (bone void filler), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the substantial equivalence determination for this bone void filler is based on the characteristics and performance of the legally marketed predicate devices (FortrOss Bone Void Filler K110561 and NanOss™ BVF-E K100361), as demonstrated through non-clinical testing. For the non-clinical tests (packaging, sterilization, etc.), the ground truth would be established by the specifications and standards (e.g., ASTM, ISO) they are tested against.

8. The Sample Size for the Training Set

Not applicable. This is a bone void filler device, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 17, 2014

Pioneer Surgical Technology, Incorporated (dba RTI Surgical, Incorporated) Ms. Sarah McIntyre Regulatory Affairs Associate II 375 River Park Circle Marquette, Michigan 49855

Re: K141600

Trade/Device Name: NanOss™, NanOss™ Loaded, NanOss™ Loaded Kit Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: September 16, 2014 Received: September 18, 2014

Dear Ms. McIntyre:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

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.

Ronald和Nean -S for

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) K141600

Device Name

NanOssTM, NanOss™ Loaded, NanOss™ Loaded Kit

Indications for Use (Describe)

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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NanOss™ Bone Void Filler 510(k) Summary Pursuant to 21 CFR 807.92

Sponsor:	Pioneer Surgical Technology, Inc.(DBA RTI Surgical, Inc.)375 River Park CircleMarquette, MI 49855 USAContact: Sarah McIntyrePh: (906) 225-5861Fx: (906) 226-4459
	Prepared: September 16, 2014
Name:	NanOss™ Bone Void Filler
Common Name:	Bone Void Filler
Trade/Proprietary	NanOss™, NanOss™ Loaded, NanOss™ Loaded Kit
ClassificationRegulations:	Filler, Bone Void, Calcium Compound (Product Code MQV)21 CFR 888.3045, Class II
Classification Panel:	Orthopaedic and Rehabilitation Devices
Predicate:	FortrOss Bone Void Filler (K110561)NanOss™ BVF-E (K100361)
Intended Use:	NanOss™ is intended for bony voids or gaps that are not intrinsic to thestability of bony structure. The product is indicated to be gently packed intobony voids or gaps in the skeletal system (i.e., extremities, posterolateralspine, and pelvis). NanOss must be mixed with autogenous blood or sterilesaline for use in the extremities or pelvis. NanOss must be mixed with bonemarrow aspirate and autograft bone as a bone graft extender in theposterolateral spine . These defects may be surgically created osseousdefects or defects created from traumatic injury to the bone. The productprovides a bone void filler that resorbs and is replaced with bone during thehealing process.
Description:	NanOss™ is a resorbable bone void filler (BVF) consisting of calciumphosphate and a porcine gelatin carrier provided in granular form. TheBVF is radiopaque, provided sterile and is intended for single use only. Theproduct is provided pre-filled in a mixing container as NanOss™ or in amixing chamber/syringe as NanOss™ Loaded.
	The purpose of this submission is to obtain clearance for a mergedindications for use statement and new packaging configuration (NanOssTMLoaded Kit). In addition, instrument accessories previously cleared for MISgraft placement in the posterolateral spine through a small incision are nowavailable for graft placement in the skeletal system (i.e., extremities, pelvis).
Testing:	The following non-clinical tests were performed to support a determinationof substantial equivalence:Packaging and Shelf-Life Validations per ASTM D4169-09: DC 13& 17 and ASTM F1980 Sterilization Validation per ISO 11137-1 Instrument Validation Testing
SubstantialEquivalence:	The bone void filler has the following similarities to the previouslycleared bone void filler product (K110561/K100361): has the same intended uses, uses the same operating principles, incorporates the same basic design, incorporates the same materials, is provided sterile and for single-use.
Conclusion:	The comparisons and testing conducted demonstrate the subject bonevoid filler product described in this submission is substantially equivalentto the predicate devices.

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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.