The GenerOs SB is an implantable device for distraction osteogenesis techniques in the small bone of the extremities. GenerOs SB is used to treat conditions where small bones of the extremities are deficient. The types of deformities that fall into this category include, but are not limited to:

Congenital deficiencies of the bones of the forearms, wrists, ankles, hands and feet;
Post-traumatic deficiencies of the bones of the forearms, wrists, ankles, hands and feet:
Deficiencies of the bones of the forearms, wrists, ankles, hands and feet due to tumor resection.
Each GenerOs SB is intended for single use only. The device is to be removed after distraction and bone stabilization are complete. It is to be used with other commercially-available accessory devices, such as bone screws for fixation to the bone surface. The device is not intended to be fixed to the bone with bone cement. However, it is possible that commercially-available bone cement may be used on the undersurface of the device to level or stabilize it on a curved surface.

Device Description

GenerOs SB is an implantable device made of surgical grade stainless steel for deficiencies of small bones of the extremities. It features two telescoping component bone plates that are distracted apart by a threaded drive shaft. The activation pin and the drive shaft are articulated using an internal gear. The device has a fixation plates on the activation and sliding block, and if not used for fixation of the device, may be easily removed. Activation of the drive shaft occurs through a transcutaneous pin. which is removed once the distraction phase is complete. The GenerOs SB implant is removed after distraction and consolidation are complete. The GenerOs SB includes reusable instruments such as activation, insertion / removal tools and other surgical instruments.
GenerOs SB is a single-use device, sold non-sterile, and requires sterilization prior to use. It is. Sterilization instructions are included in the labeling.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the GenerOs SB Small Bone Distraction Implant. This document focuses on establishing substantial equivalence to existing predicate devices rather than presenting a study demonstrating performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment cannot be extracted directly from this submission.

Here's a breakdown of what can be inferred or stated based on the provided text:

1. A table of acceptance criteria and the reported device performance

The submission does not provide a table of acceptance criteria with corresponding performance results. Instead, it states that "Performance of the GenerOs SB has been substantiated by biocompatibility, sterilization, packaging validation, and mechanical tests in conformance to standard testing quidelines for bone plate implant devices." However, specific quantitative acceptance criteria or detailed performance data from these tests are not provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission focuses on substantial equivalence based on design, materials, function, and intended use, rather than clinical efficacy studies requiring specific test set sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided because there is no clinical study mentioned that would require establishing a ground truth by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as there is no mention of a clinical study that would involve expert adjudication.

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

There is no mention of an MRMC study, AI assistance, or human readers in this document. The device is a physical, implantable medical device, not an AI-powered diagnostic or assistive tool.

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

This is not applicable as the device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Since no clinical study with a test set is described, there is no mention of the type of ground truth used. The submission relies on substantial equivalence to predicate devices, implying that the safety and effectiveness are supported by the established performance of those predicates and general performance testing (biocompatibility, mechanical, etc.).

8. The sample size for the training set

This information is not applicable as the device is a physical implant, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable as the device is a physical implant, not a machine learning model.

Summary of what is present:

The document serves as a 510(k) premarket notification declaring that the GenerOs™ SB Small Bone Distraction Implant is substantially equivalent to legally marketed predicate devices. The basis for this claim is:

Identical features and technology to K993869 (GenerOs CF Craniofacial Bone Generator), with the only difference being the indication for use.
Comparison of features and indications for use to K031875 (OrthoNetx' Limb Lengthener).
Comparison of indications for use to K040907 (Arthrex Small Fragment Plates and Screws), K992961 (Lorenz Small Fragment System), and K050110 (LCP Modular Foot Plates).
Performance substantiated by:
- Biocompatibility tests
- Sterilization validation
- Packaging validation
- Mechanical tests

These tests were performed "in conformance to standard testing guidelines for bone plate implant devices," which implies that the device met industry-standard acceptance criteria for those specific performance areas, even if those criteria are not explicitly detailed in this document. The core argument for acceptance is substantial equivalence to already cleared devices, meaning the FDA did not require new clinical effectiveness studies for this particular submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for OrthoNet Incorporated. The logo features a stylized eye graphic on the left, followed by the company name in a blocky, sans-serif font. Below the name, in smaller font, is the tagline "the osteoplastic surgery company".

510(k) Premarket Notification JUL 1 9 2005 GenerOs SB Small Bone Distraction Implant

Section 1.3

Summary of Safety and Effectiveness

REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

COMPANY NAME/CONTACT

Terry Knapp, MD OrthoNetx, Inc. 1000 S. McCaslin Blvd, Suite 300 Superior, CO 80027 Voice: 303.494.1681 x 301 FAX: 303.494.1714

NAME OF DEVICE

Trade Name:	GenerOs™ SB Small Bone Distraction Implant
Common Name:	Internal Bone Plate Distractor
Common Description:	Single/Multiple component metallic bone fixationappliance and accessories

Classification Names:

RegulationNumber	ProductCode	Classification Name	DeviceClass
21 CFR888.3030	KTT	Appliance, fixation,nail/blade/platecombination, multiplecomponent	II
21 CFR888.3030	HRS	Plate, Fixation, Bone	II

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Image /page/1/Picture/1 description: The image shows the logo for OrthoNet Incorporated. The logo features a stylized eye-like symbol on the left, followed by the word "OrthoNet" in a modern, sans-serif font. Below "OrthoNet," the word "Incorporated" is written in a smaller font, and below that is the tagline "the osteoplastic surgery company".

DEVICE DESCRIPTION

GenerOs SB is a single-use device, sold non-sterile, and requires sterilization prior to use. It is. Sterilization instructions are included in the labeling.

INDICATION FOR USE STATEMENT

Congenital deficiencies of the bones of the forearms, wrists, ankles, hands . and feet;
. Post-traumatic deficiencies of the bones of the forearms, wrists, ankles, hands and feet:
Deficiencies of the bones of the forearms, wrists, ankles, hands and feet due . to tumor resection.

Each GenerOs SB is intended for single use only. The device is to be removed after distraction and bone stabilization are complete. It is to be used with other commercially-available accessory devices, such as bone screws for fixation to the bone surface. The device is not intended to be fixed to the bone with bone cement. However, it is possible that commercially-available bone cement may be used on the undersurface of the device to level or stabilize it on a curved surface.

PREDICATE DEVICES

GenerOs Bone Generator; OrthoNetx, Inc. (formerly Inter-Os Technologies) . (#K993869)
Limb Lengthener; OrthoNetx, Inc, (#K031875) ●
Arthrex Small Fragment Plates and Screws; Arthrex, Inc., (#K040907) .
Lorenz Small Fragment System (#K992961); Walter Lorenz Surgical, Inc.
LCP Modular Foot Plates; Synthes (USA), (#K050110)

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Image /page/2/Picture/0 description: The image shows the logo for OrthoNet Incorporated. The logo features a stylized eye graphic on the left, followed by the word "OrthoNet" in a bold, sans-serif font. Below "OrthoNet" is the text "Incorporated X." and the tagline "the osteoplastic surgery company".

SUBSTANTIAL EQUIVALENCE COMPARISON

The GenerOs SB is identical in features and technology to the GenerOs CF Craniofacial Bone Generator (#K993869); the only difference is the indication for use.

The features and indications for use are compared to OrthoNetx' Limb Lengthener (#K031875).

Indications for use are compared to Arthrex Small Fragment Plates and Screws by Arthrex, Inc., (#K040907); Lorenz Small Fragment System (#K992961) by Walter Lorenz Surgical, Inc. and LCP Modular Foot Plates by Synthes (USA), (#K050110).

The GenerOs SB is substantially equivalent to predicate devices based on the descriptive characteristics, similar intended use, and same principle operation of distraction osteogenesis.

PERFORMANCE

Performance of the GenerOs SB has been substantiated by biocompatibility, sterilization, packaging validation, and mechanical tests in conformance to standard testing quidelines for bone plate implant devices.

CONCLUSION

Based on the design, materials, function, intended use, the GenerOs SB is substantially equivalent to the devices currently cleared under the Federal Food, Drug and Cosmetic Act. The GenerOs SB Distraction Implant raises no new safety or effectiveness issues. Therefore, safety and effectiveness are reasonably assured, iustifying 510(k) clearance for the GenerOs SB Distraction Implant.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 19 2005

Terry Knapp, M.D. CEO OrthoNetX, Inc. 1000 S. McCaslin Blvd. Suite 300 Superior, Colorado 80027

Re: K051162

Trade/Device Name: GenerOs™ SB Small Bone Distraction Implant Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT, HRS Dated: May 4, 2005 Received: May 5, 2005

Dear Dr. Knapp:

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

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Page 2 - Dr. Knapp

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket nother in the r DAY midning of backand of ...
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 If you desire specific advice for your accept (240) 276-0120. Also, please note the regulation entitled, Comaci the Office of Compilance in (21 transmit (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Eun A. Kim

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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OrthoNet
Incorporated
"the osteoplastic surgery company"

Section	1.2
---------	-----

Indications for Use Statement

510(k) Number:

Device Name:

GenerOs™ SB Small Bone Distraction Implant

Indications for Use:

The GenerOs SB is an implantable device for distraction osteogenesis techniques in t the GenerOs SB is an implantable downed to treat conditions where the small bone of the extremities are deficient. The types of deformities that fall into this ategory include, but are not limited to:

Congenital deficiencies of the bones of the forearms, wrists, ankles, hands and feet:
and leet,
Post-traumatic deficiencies of the bones of the forearms, wrists, ankles, hands and feet;
and leet, to tumor resection.

Each GenerOs SB is intended for single use only. The device is to be removed after . Lach OcherOS OD is intonuba so ere complete. It is to be used with other distraction and bone stablization are semplotes, such as bone screws for fixation to the commercially-available accessery do heef on the bone with bone with bone with bone cement.
The bone surface. The device is not intended to be fixed to the word on the . However, it is possible that commercially-available bone cement may be used on the undersurface of the device to level or stabilize the GenerOs SB on a curved surface.

Prescription Use	XX	or	Over-The-Counter Use
(Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Confidential	K051162 1-2
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Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.