The Distal Femoral Growing Prosthesis is indicated for pediatric patients who have not achieved full skeletal maturity (open epiphysis), where radical resection and replacement of the distal femur and or/proximal tibia is required with the following conditions:

. Oncology indications
Severe trauma .
. Noninflammatory degenerative joint disease including osteoarthritis
. Correction of functional deformity
. Rheumatoid arthritis
. Revision procedures where other treatments or devices have failed

The devices are single use implants intended only for implantation with bone cement.

Compatible components of the GMRS, MRH, MRS, and KRH when used with the Distal Femoral Growing Prosthesis are intended for use in pediatric patients for the abovementioned indications.

Device Description

The Distal Femoral Growing Prosthesis System provides a means to reconstruct large bone defects resulting from bone resection in skeletally immature patients. The device can be expanded as a patient grows so that leg-length equality can be achieved. The device utilizes a rotating hinge design. The expansion process is mechanical and is conducted with subsequent minimally invasive procedures following the initial implantation surgery.

AI/ML Overview

Acceptance Criteria and Device Performance Study for the Distal Femoral Growing Prosthesis System

The provided document describes the "Distal Femoral Growing Prosthesis System" and its substantial equivalence to predicate devices, without detailed acceptance criteria typically found for diagnostic or AI-driven devices. This submission for K122015 is for a medical implant (prosthesis), and its "acceptance criteria" are primarily related to its mechanical performance and compliance with established standards for such devices, rather than a diagnostic accuracy or efficacy typical for AI-enabled devices.

Here's an interpretation of "acceptance criteria" and "device performance" based on the provided text, focusing on the non-clinical testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical Stability during Expansion Feature Operation: The expansion feature of the device must not cause collapse/retraction before, during, or after physiological loading. (Implied for safe and effective longitudinal growth adjustment)	"Single-axis and multi-axis life cycle testing of the Distal Femoral Growing Prosthesis was conducted to verify that the expansion feature of the device will not cause the subject component to collapse/retract before, after and during physiological loading. All specimens tested ran out without evidence of collapse of the device."
Fatigue Resistance of Crossover Bearing Component: The crossover bearing component must withstand physiological loading. (Implied for long-term durability and function)	"Fatigue testing was also conducted on the Distal Femoral Growing Prosthesis crossover bearing component. All test specimens withstood physiological loading as compared to the predicate device."
Substantial Equivalence to Predicate Devices: Technological characteristics (material, design, sizes, operational principles) should be similar or identical to predicate devices. (A regulatory acceptance criterion for 510(k) clearance)	"The technological characteristics (material, design, sizes, and operational principles) of the Distal Femoral Growing Prosthesis System are similar or identical to its predicate devices." and "The Distal Femoral Growing Prosthesis System devices are substantially equivalent to the predicate devices identified in this premarket notification."

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

Sample Size: The document does not specify the exact number of "specimens" tested for single-axis, multi-axis life cycle testing, or fatigue testing. It refers to "All specimens tested" and "All test specimens," implying a sufficient number were used to demonstrate the stated performance.
Data Provenance: The testing was "Non-clinical laboratory testing." This indicates the data was generated in a controlled laboratory environment, not from patient data, and is thus prospective in nature for the purpose of design verification. The country of origin for the lab is not specified.

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

This is not applicable for this type of device and testing. The "ground truth" for mechanical testing is established by engineering specifications, material science principles, and established testing standards (e.g., ISO, ASTM for similar medical devices). There are no human "experts" establishing a diagnostic ground truth in this context.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical mechanical testing. Adjudication methods like 2+1 or 3+1 are used to establish ground truth for clinical cases, often in diagnostic studies where expert consensus is needed.

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

No, an MRMC comparative effectiveness study was not done. Such studies are typically conducted for devices that assist human interpretation (e.g., AI for radiology). This submission is for a prosthetic implant whose performance is assessed through mechanical and material testing, not human interpretation. The document explicitly states: "Clinical testing was not required for this submission."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a physical prosthesis, not an algorithm or AI system. Its "performance" is inherently standalone in the sense that its mechanical properties are evaluated intrinsically, without human interaction during the test itself (though humans design the test).

7. The Type of Ground Truth Used

The ground truth for this device's acceptance criteria primarily involved engineering specifications, established biomechanical performance standards for orthopedic implants, and comparison to predicate device performance. This is validated through laboratory testing designed to simulate physiological loads and growth expansion cycles.

8. The Sample Size for the Training Set

This concept is not applicable. "Training set" refers to data used to train machine learning models. This device is a mechanical prosthesis and does not involve any machine learning components.

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

This question is not applicable, as there is no training set for a mechanical prosthetic device.

Summary

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K122015

510(k) Summary of Safety and Effectiveness

FEB 2 2 2013

Proprietary Name:	Distal Femoral Growing Prosthesis System
Common Name:	Knee Replacement Prosthesis and ModularRotating Hinge Knee
Classification Name and Reference:	Prosthesis, Knee, Femorotibial, Constrained,Cemented, Metal/Polymer21 CFR § 888.3510
Proposed Regulatory Class:	Class II
Product Codes:	87KRO: Knee Joint Femorotibial Metal/PolymerConstrained Cemented Prosthesis
For Information Contact:	Christie PencingerRegulatory Affairs AssociateHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6365; Fax (201)831-3365
Legally Marketed Devices to WhichSubstantial Equivalence Is Claimed:	K020381: Expandable KneeK023087: Global Modular Replacement System(GMRS)K965164: Howmedica Modular ReplacementSystem-Proximal Femur
Date Prepared:	November 26, 2012

Description

Intended Use

The Distal Femoral Growing Prosthesis System offers a treatment option for patients requiring distal femoral replacement who have not achieved full skeletal maturity (open epiphysis). The devices are single use implants.

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Indications

The Distal Femoral Growing Prosthesis is indicated for pediatric who have not achieved full skeletal maturity (open epiphysis), where radical resection and replacement of the distal femur and or/proximal tibia is required with the following conditions:

. Oncology indications
Severe trauma .
Noninflammatory degenerative joint disease including osteoarthritis .
Correction of functional deformity ◆
Rheumatoid arthritis ●
Revision procedures where other treatments or devices have failed .

The devices are single use implants and intended only for implantation with bone cement.

Compatible components of the GMRS, MRH, MRS, and KRH when used with the Distal Femoral Growing Prosthesis are intended for use in pediatric patients for the abovementioned indications.

Summary of Technologies

The technological characteristics (material, design, sizes, and operational principles) of the Distal Femoral Growing Prosthesis System are similar or identical to its predicate devices.

Non-Clinical Testing

Non-clinical laboratory testing was performed to determine substantial equivalence. Single-axis and multi-axis life cycle testing of the Distal Femoral Growing Prosthesis was conducted to verify that the expansion feature of the device will not cause the subject component to collapse/retract before, after and during physiological loading. All specimens tested ran out without evidence of collapse of the device. Fatigue testing was also conducted on the Distal Femoral Growing Prosthesis crossover bearing component. All test specimens withstood physiological loading as compared to the predicate device.

Clinical Testing

Clinical testing was not required for this submission.

Conclusion

The Distal Femoral Growing Prosthesis System devices are substantially equivalent to the predicate devices identified in this premarket notification.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The text is in all capital letters and is black. The eagle is also black and is facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

February 22, 2013

Howmedica Osteonics Corporation % Ms. Christie Pencinger Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430

Re: K122015

Trade/Device Name: Distal Femoral Growing Prosthesis System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: December 20, 2012 Received: December 21, 2012

Dear Ms. Pencinger:

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

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Page 2 -- Ms. Christie Pencinger

device-related adverse events) (21 CFR 803); 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.

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 vours.

Erin.DKeith

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

Enclosure

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Indications for Use

510(k) Number (if known): K122015

Device Name: Distal Femoral Growing Prosthesis System

Indications

. Oncology indications
Severe trauma .
. Noninflammatory degenerative joint disease including osteoarthritis
. Correction of functional deformity
. Rheumatoid arthritis
. Revision procedures where other treatments or devices have failed

The devices are single use implants intended only for implantation with bone cement.

Compatible components of the GMRS, MRH, MRS, and KRH when used with the Distal Femoral Growing Prosthesis are intended for use in pediatric patients for the abovementioned indications.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

3.02.22 09:58:36 Page 1 of 1 Anton E. Dmitriev, PhD Division of Orthopedic Devices L

Regulation Number and Section

§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.