The OSS Bone Graft System and the OSS RapidSet Bone Graft System are indicated for filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. The device is intended for bone voids or gaps that are not intrinsic to the structural integrity of the bony structure.

Device Description

OSS Bone Graft System and OSS RapidSet Bone Graft System are packaged as separate, pre-measured powder and liquid components. The two components are to be mixed intraoperatively to produce a homogenous paste that can be applied to bone gaps or defects. The powder component is a mixture of a ceramic calcium phosphate powder and sodium citrate dihydrate. The liquid component is a solution comprised of anhydrous citric acid (C6H8O7) and distilled water (H2O). When mixed, the powder and liquid combine to form a homogenous paste.

AI/ML Overview

The provided text describes the 510(k) summary for the Biomet OSS Bone Graft System and OSS RapidSet Bone Graft System. Based on the document, here's an analysis of the acceptance criteria and study information:

Key Finding: The submission states "Clinical Testing: None provided," meaning no specific human clinical study was conducted to prove the device met acceptance criteria, as it was cleared through the 510(k) substantial equivalence pathway. The clearance relies primarily on non-clinical testing and similarity to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Material Composition	Not explicitly stated as "acceptance criteria," but implied that composition should be safe and effective for its intended use.	"The materials, design and processing OSS Bone Graft System and OSS RapidSet Bone Graft System are similar or identical to the predicate products."	Substantial equivalence to predicate devices (K990290, K023718, K003494, K011048, K011897, K990131) forms the basis for acceptance. The device is a "mixture of a ceramic calcium phosphate powder and sodium citrate dihydrate" for the powder, and "anhydrous citric acid (C₆H₈O₇) and distilled water (H₂O)" for the liquid.
Physical/Chemical Properties
Elemental Analysis	Not explicitly stated as acceptance criteria.	Elemental analysis was performed.	This testing likely confirms the material composition and purity.
Set Time	Not explicitly stated as acceptance criteria, but implies a functional set time suitable for surgical application.	Determination of set time was performed.	Essential for surgeons to have a predictable working time.
X-ray Diffraction Analysis	Not explicitly stated as acceptance criteria.	X-ray diffraction analysis was performed.	Used to characterize the crystalline structure of the ceramic component.
Surface pH	Not explicitly stated as acceptance criteria, but crucial for biocompatibility.	Determination of surface pH was performed.	Surface pH needs to be within a biocompatible range to avoid adverse tissue reactions.
Exothermic Temperature	Not explicitly stated as acceptance criteria, but critical for patient safety during application.	Exothermic temperature was determined.	Excessive heat generation during setting could cause tissue damage.
Biocompatibility	Not explicitly stated as "acceptance criteria," but implied based on the nature of an implantable device.	Not explicitly detailed, but usually covered by material composition similarity to known biocompatible predicate devices or standard biocompatibility testing.	The 510(k) process often relies on existing data for predicate devices.
Sterility	Not explicitly stated as "acceptance criteria."	Not explicitly detailed.	Implied requirement for a device intended for surgical implantation, usually demonstrated through validation of sterilization processes.
Intended Use	Device must be suitable for "filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis)" where defects are "surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone." The device is intended "for bone voids or gaps that are not intrinsic to the structural integrity of the bony structure."	The device is cleared for this intended use based on substantial equivalence.
Clinical Performance	Not applicable for this submission.	None provided.	The submission explicitly states no clinical testing was performed.

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

Sample Size: Not applicable. No clinical test set data was provided or used for evaluation in this 510(k) submission.
Data Provenance: Not applicable. No clinical data was used. The submission relies on non-clinical testing and comparison to legally marketed predicate devices.

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

Not applicable. No clinical test set was used, therefore no experts were required to establish ground truth for clinical performance. The assessment was based on FDA reviewers evaluating the non-clinical data and predicate device comparisons.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was used.

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

No. The document explicitly states "Clinical Testing: None provided."

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

Not applicable. This is a bone graft substitute, not an AI algorithm or diagnostic device.

7. The Type of Ground Truth Used

Non-Clinical Data: The "ground truth" for the non-clinical testing (elemental analysis, set time, X-ray diffraction, surface pH, exothermic temperature) would be established by standard laboratory methods and specifications for biomaterials.
Substantial Equivalence: The primary "ground truth" for regulatory acceptance in this case is the established safety and effectiveness of the legally marketed predicate devices to which the OSS Bone Graft System is deemed "substantially equivalent." This means that the predicate devices, having gone through their own clearance processes (which may or may not have involved clinical trials depending on their regulatory pathway), served as the benchmark.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device.

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

Not applicable. This is not a machine learning or AI device.

Summary

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K04-1089

AUG 3 1 2004

BIOMET

510(k) Summary

Applicant/Sponsor:Biomet Manufacturing Corp. P.O. Box 587 Warsaw, IN 46581

Patricia Sandborn Beres Contact Person: Senior Requlatory Specialist

Proprietary Name: OSS Bone Graft System and OSS RapidSet Bone Graft System

Common Name: Bone Graft Substitute

Classification Name: Resorbable calcium salt bone void filler device (21 CFR 888.3045)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The current product is identical to the material previously cleared through 510(k)s K990290, ourrent pland K023718 for craniofacial applications and K003494 for dental applications.

Products cleared for orthopedic applications include: α-BSM® Bone Substitute Material (K011048), Norian® SRS® Bone Void Filler (K011897) and Pro Osteon® 500R Resorbable Bone Graft Substitute (K990131).

Device Description: OSS Bone Graft System and OSS RapidSet Bone Graft System are packaged as separate, pre-measured powder and liquid components. The two components are to be mixed intraoperatively to produce a homogenous paste that car be applied to bone gaps or defects.

The powder component is a mixture of a ceramic calcium phosphate powder and sodium citrate dihydrate. The liquid component is a solution comprised of anhydrous citric acid (C,H,O,) and distilled water (H₂O). When mixed, the powder and liquid combine to form a homogenous paste.

Intended Use: The OSS Bone Graft System and the OSS RapidSet Bone Graft System are indicated for filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. The device is intended for bone voids or gaps that are not intrinsic to the structural integrity of the bony structure.

Image /page/0/Figure/14 description: The image shows the mailing address, shipping address, office number, fax number, and email address. The mailing address is P.O. Box 587, Warsaw, IN 46581 0587. The shipping address is 56 E. Bell Drive, Warsaw, IN 16582. The office number is 574.267.6639, the fax number is 574.267.8137, and the email address is biomet@biomet.com.

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Summary of Technologies: The materials, design and processing OSS Bone Graft System and OSS RapidSet Bone Graft System are similar or identical to the predicate products.

Non-Clinical Testing: Non-clinical testing provided included elemental analysis, a determination of set time, X-ray diffraction analysis, determination of surface pH, and exothermic temperature.

Clinical Testing: None provided

Mimix is a trademark of Walter Lorenz Surgical, a Biomet Company Tyvek is a trademark of trademark of E.I. duPont de Nemours and Company α-BSM is a trademark of DePuy Pro Osteon is a trademark of Interpore Cross International

Norian and SRS are trademarks of Synthes

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which represent the department's mission to enhance the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2004

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corporation P.O Box 587 Warsaw, Indiana 46581-0587

Re: K041089

OSS Bone Graft System and OSS RapidSet Bone Graft System Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: July 19, 2004 Received: July 20, 2004

Dear Ms. Sandborn Beres:

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 (OS) regulation (21 CFR Part 820); and if

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Page 2 - Ms. Patricia Sandborn Beres

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you be object finding of substantial equivalence of your device to a premarket notification. - The PD Frinalis 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), If you desire specific at no for compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn other generalational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

l Mark H. Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: OSS Bone Graft System and OSS RapidSet Bone Graft System

Indications For Use:

The OSS Bone Graft System and the OSS RapidSet Bone Graft System are indicated
System of the Caster Charline (increating and nelvis) The USS Bone Grant System and the OOO Representities, spine and pelvis).
for filling bony voids of the skeletal system (i.e., the extremes defects creat for filling bony volus of the skeller system (r.c.) the exarch or osseous defects created
These defects may be surgically created osseous in intended for hope voids or i hese defects may be suigically created observes in intended for bone voids or
from disease or traumatic injury to the bone. The device is intentire from disease of traumatio injury to the structural integrity of the bony structure.

Prescription Use X (Per 21 CFR 801.109) OR

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)

for Mark N Milker
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number_ K041089

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.