Genex® Putty is a bone void filler intended to fill defects not intrinsic to the stability of the spine and pelvis. Genex® Putty provides a bone void filler that resorbs and is replaced with bone during the healing process.

Device Description

Genex® Putty is a calcium salt bone graft substitute and is provided sterile for single patient use. When Genex® Putty is placed in the defect; bone grows in apposition to the implant, filling the pores with new bone during the healing process. Genex® Putty is completely resorbed and replaced with bone during the healing process.

AI/ML Overview

This 510(k) summary for the Genex® Putty does not contain detailed information regarding acceptance criteria or a specific study proving the device meets those criteria in the way one might expect for a diagnostic or AI-driven device.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, which is the typical path for 510(k) clearances for relatively straightforward medical devices like bone void fillers. This means the key "acceptance criteria" revolve around showing similarity in intended use, technological characteristics, safety, and effectiveness to an already legally marketed device.

Here's an attempt to structure the information based on your request, highlighting what is (and isn't) present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance
Safety and Effectiveness (Substantial Equivalence)	Documented to be "substantially equivalent to the legally marketed predicate device in basic features and intended uses. No new concerns have been identified regarding safety and effectiveness of the new device." "The indications, contraindications, risks and potential adverse events are the same as the identified predicate device and are thus substantially equivalent."
Technological Characteristics	"Genex® Putty has the same technological characteristics as the predicate device and any differences do not raise any concerns regarding safety and effectiveness."
Intended Use	"Genex® Putty is a bone void filler intended to fill defects not intrinsic to the stability of the spine and pelvis." This matches the predicate device's intended use.
Resorption and Replacement with Bone (Functional Equivalence)	"Genex® Putty provides a bone void filler that resorbs and is replaced with bone during the healing process." This is a key functional claim, implicitly demonstrated to be equivalent to the predicate device.

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

None stated. The document does not describe a clinical "test set" in the context of human subjects or a clinical trial with specific sample sizes. The evaluation is based on non-clinical testing and comparison to a predicate device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This type of information is relevant for studies involving human interpretation (e.g., radiology reads) where ground truth needs to be established by panels of experts. For a bone void filler comparison, this concept doesn't directly apply. The "ground truth" here is regulatory acceptance of the predicate device and the non-clinical data demonstrating equivalency.

4. Adjudication Method for the Test Set

Not applicable. As there's no described "test set" requiring expert interpretation, no adjudication method is detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, not applicable. An MRMC study is relevant for diagnostic devices (e.g., imaging AI) where human readers' performance with and without AI assistance is compared. This device is a biomaterial, not a diagnostic tool, so such a study would not be performed.

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

No, not applicable. This device is a physical bone void filler, not an algorithm or AI system.

7. The Type of Ground Truth Used

For this device, the "ground truth" is established through:
- Regulatory acceptance of the predicate device: The predicate device itself serves as the benchmark for safety and effectiveness.
- Non-clinical testing: This would involve laboratory data (e.g., material properties, biocompatibility, mechanical strength, resorption rates) demonstrating that Genex® Putty performs similarly to the predicate device. Specific details of these tests are not provided in the summary but would be part of the full 510(k) submission.

8. The Sample Size for the Training Set

Not applicable. This concept is relevant for machine learning algorithms. The Genex® Putty is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As above, this device does not involve a training set.

Summary of Study (Implicit)

The "study" presented in this 510(k) summary is not a traditional clinical trial or performance study with defined acceptance criteria for novel performance metrics. Instead, it is a substantial equivalence review.

The document indicates:

Non-Clinical Testing: Data supplied demonstrates that Genex® Putty is substantially equivalent to the predicate device. This implies laboratory tests were performed to compare material properties, biological interactions (e.g., biocompatibility), and functional characteristics (e.g., resorption). The specifics of these tests are not provided in this summary.
Comparison to Predicate: The core of the "study" is the comparison of Genex® Putty's indications, contraindications, risks, potential adverse events, and technological characteristics to an already legally marketed predicate device. The conclusion is that they are the "same" or that differences do "not raise any concerns regarding safety and effectiveness."

In essence, the "acceptance criteria" for Genex® Putty were met by demonstrating its equivalence to a predicate device through non-clinical data, rather than through a novel clinical study with a predefined performance endpoint and sample size.

Summary

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KO73341

510(k) SUMMARY

JUL - 9 2008

Genex® Putty

Applicant

Biocomposites Ltd Keele Science Park Keele Staffordshire England ST5 SNL

Contact Person

Mr Simon Fitzer Tel: +44 (0) 1782 338580 +44 (0) 1782 338599 Fax Email: sf@biocomposites.com

Classification Name: Common/Usual Name: Trade/Proprietary Name Product Code

Filler, bone void, calcium compound Bone void filler Genex® Putty MQV

Device Description

Genex® Putty is completely resorbed and replaced with bone during the healing process.

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K073341 (pg. 1 of 2)

Intended Use / Indications

Genex® Putty is a bone void filler intended to fill defects not intrinsic to the stability of the spine and pelvis.

Genex® Putty provides a bone void filler that resorbs and is replaced with bone during the healing process.

Summary of Technology

Genex® Putty has the same technological characteristics as the predicate device and any differences do not raise any concerns regarding safety and effectiveness.

Genex® Putty provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

The indications, contraindications, risks and potential adverse events are the same as the identified predicate device and are thus substantially equivalent.

Non Clinical Testing

Data supplied demonstrates that Genex® Putty is substantially equivalent to the predicate device and any differences do not raise any concerns regarding safety and effectiveness.

Substantial Equivalence

Documentation provided demonstrates that the Genex® Putty is substantially equivalent to the legally marketed predicate device in basic features and intended uses. No new concerns have been identified regarding safety and effectiveness of the new device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, with three curved lines forming the body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biocomposites Ltd. % Mr. Simon Fitzer Keele Sciences Park Keele, Staffordshire United Kingdom ST5 5NL

JUL - 9 2008

Re: K073341

Trade/Device Name: Genex® Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone filler device Regulatory Class: Class II Product Code: MQV Dated: July 3, 2008 Received: July 7, 2008

Dear Mr. Fitzer:

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 - Mr. Simon Fitzer

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 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,

Mark M. Millerson

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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INDICATIONS FOR USE

510(k) Number (if known):

Genex® Putty Device Name:

Indications For Use:

Genex® Putty is a bone void filler intended to fill defects not intrinsic to the stability of the spine and pelvis.

Genex® Putty provides a bone void filler that resorbs and is replaced with bone during the healing process.

Prescription Use (Part 21 CFR 801 Subpart D)

Over
(Part

No Over-The-Counter use (Part 21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jarlare Buerno

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K67 334/

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.