The Osseoflex® SB is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal polymethymethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.

Device Description

The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® needle to fill the previously created void(s).

An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device. The articulating or steering feature of the device assists the clinician in directing the device to the pre-existing channel. The Osseoflex® SB knob can be turned clockwise to aid in directing the distal portion of the device. Turning the knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.

AI/ML Overview

The Osseoflex® SB is an inflatable bone tamp designed for use in balloon kyphoplasty to create a cavity in the vertebral body for cement interdigitation, and to reduce fractures.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Standard/Test/FDA Guidance)	Reported Device Performance (Results Summary)
Inflation Pressure	Constrained Burst Test	The balloon catheter exceeded the requirements for the minimum burst pressure in a constrained environment.
Inflation Volume	Unconstrained Burst Test	The balloon catheter exceeded the requirements for the minimum burst volume in an unconstrained environment.
Balloon Double Wall Thickness	Calibrated Measurement	The double wall thickness of the balloon was substantially equivalent to that of the predicate devices.

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

The provided document does not mention a test set with a specific sample size. The studies conducted were non-clinical performance tests rather than tests involving patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in this context.

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

Not applicable. The reported studies are non-clinical performance tests (mechanical and material characteristic tests), not studies requiring expert review of data for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring expert adjudication was described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "N/A – No clinical test were conducted for this submission." Therefore, an MRMC comparative effectiveness study was not performed.

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

No. This device is a physical medical device (inflatable bone tamp), not an algorithm or AI software. Therefore, the concept of standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests was established by predefined engineering and material science requirements and standards for medical devices (e.g., minimum burst pressure, minimum burst volume, and material specifications). These are objective measurements rather than subjective expert interpretations.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or software device that undergoes training.

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

Not applicable, as there is no training set for a physical medical device.

Summary

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OCT 2 3 2012

510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.

510(k) Owner

Osseon® Therapeutics, Inc. 2330 Circadian Way Santa Rosa, CA 95407 Phone: 707-636-5940 Fax: 707-636-5941

Official Contact

Keith Burger Director of Research and Development

Device Information

Trade or ProprietaryName:	Osseoflex® SB
Common Name:	Inflatable Bone Tamp
Classification Name:	Primary: ArthroscopeSecondary: Cement, Bone Vertebroplasty
Classification Panel:	Orthopedic
Regulation:	Class II per 21CFR §888.1100, Procode HRXClass II per 21CFR §888.3027. Procode NDN
Product Code(s)	OF-0005
Legally marketed device(s)to which equivalence isclaimed	Kyphon Inflatable Bone Tamp, K041454, K032212, K010246, K981251CareFusion Inflatable Bone Tamp, K103064, K093463, K090211
Reason for 510(k)	New Device
Device Description	The Osseoflex® SB is designed for use in balloon kyphoplasty. Theballoon serves to create a cavity in the vertebral body, thereby reducing thefracture while still allowing for cement interdigitation. The balloon catheteris the functional part of the device that creates a cavity and reduces thefracture. The balloon catheter provides a conduit through which thephysician can inflate the balloon at the distal end of the catheter. After thebone is disrupted, PMMA is injected through an Osseoflex® needle to fillthe previously created void(s).An access channel is required for Osseoflex® SB placement. TheOsseoflex® SB device does not create an access channel; the Osseoflex® SBis designed to follow a pre-existing channel created by an access channeldevice. The articulating or steering feature of the device assists the clinicianin directing the device to the pre-existing channel. The Osseoflex® SB knobcan be turned clockwise to aid in directing the distal portion of the device.Turning the knob counter-clockwise will relax the device and allow the

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device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.

Intended Use

Summary of Technological Characteristics of the Device Compared to the Predicate Devices
Characteristic	New Device	Predicate Device
Trade Name	Osseoflex SB	Kyphon IBT (K041454,K032212, K010246,K981251)	CarefusionAVAmax VertebralBalloon (K103064,K093463, K090211)
Cannula size	8G	8G	8G
Balloon InflationMedium	60% Contrast	60% Contrast	60% Contrast
Balloon Material	Polyurethane	Polyurethane	Polyurethane
Balloon Size	15mm	10, 15, and 20mm	10, 15, and 20mm
15mm Balloon Diameterat nominal volume (2ml)	10.2mm	8.5mm	11.8mm
15mm 'Balloon Lengthat nominal volume (2ml)	13.7mm	14.6mm	14.9mm
Balloon Shape	Cylindrical	Variable	Cylindrical
Max inflation pressure	400 psi (27 ATM)	400 psi (27 ATM)	400 psi (27 ATM)
Max inflation volume	4ml	4ml	4ml

Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence Toct Summa Douts C

Performance Test Summary – Osseoflex SB
Characteristic	Standard/ Test/FDA Guidance	Results Summary
Inflation Pressure	Constrained BurstTest	The balloon catheter exceeded the requirements forthe minimum burst pressure in a constrainedenvironment
Inflation Volume	UnconstrainedBurst Test	The balloon catheter exceeded the requirements forthe minimum burst volume in an unconstrainedenvironment
Balloon DoubleWall Thickness	CalibratedMeasurement	The double wall thickness of the balloon wassubstantially equivalent to that of the predicate devices
Summary of Clinical Tests Conducted for Determination of Substantial Equivalence
N/A – No clinical test were conducted for this submission
Conclusions Drawn from Non-Clinical and Clinical Data
The results of the non-clinical tests show that the Osseoflex SB meet or exceed all performancerequirements and are substantially equivalent to the predicate devices

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

Osseon® Therapeutics, Incorporated % Mr. Keith Burger Director of Research and Development 2330 Circadian Way Santa Rosa, California 95407

Re: K122533

Trade/Device Name: Osseoflex® SB Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: October 5, 2012 Received: October 11, 2012

Dear Mr. Burger:

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

OCT
23 2012

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Page 2 -- Mr. Keith Burger

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

David Krone

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

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INDICATION FOR USE STATEMENT 12.0

K122533 510 (k) Number:

Osseoflex® SB Device Name:

Indication For Use:

The Osseoflex® SB is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

(Division Sign-Om Division of Surgical, Ofthopedic, and Restorative Devices

510(k) Number K122533

Osseon Therapeutics Incorporated Osseoflex® SB Steerable Bone Tamp 510(k) — K122533

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”