The FITBONE® TAA System is a fully implantable intramedullary lengthening device. Changes to the existing FITBONE® TAA (K163368) have been introduced to extend the current portfolio by new Subject FITBONE® TAA09 intramedullary lengthening nail model fixed to the bone by new Subject Locking Screws and a new Subject Receiver connected to the Subject nail by a bipolar feed line with new Subject external Retraction Control Set consisting of a control electronics with a Retraction Transmitter. New Subject surgical tools are provided to facilitate the surgical process.

The Subject FITBONE® TAA09 intramedullary lengthening nail model, line extension of the primary predicate FITBONE® TAA (Κ163368) models is implanted into the medullary canal of the femur or tibia. The nail is fixed to the bone by Locking Screws through longitudinal openings in the nail.

The Subject FITBONE® TAA09 intramedullary lengthening nail consists of a telescoping system that allows it to expand. It is powered by hermetically enclosed electromagnetic motor which draws the telescope apart, during which the extension is externally steered via electronic impulses. The Subject FITBONE® TAA09 intramedullary lengthening nail elongation is propelled by a highly sensitive gear and spindle mechanism which converts the rotation of the motor into an axial movement with high force.

The energy needed for the distraction process of the nail is transmitted from the outside by placing the external Transmitter over the implanted Receiver which is placed in the subcutaneous tissue during FITBONE® surgery. The energy transmission will be triggered by pressing the "Patient" button on the control electronics by the patient. There is no transcutaneous contact between the implanted intramedullary nail and the outer surface of the patient's body.

The nail and Receiver are offered in sterile conditions and the Locking screws and non-implantable external electronic controlling components in non-sterile packaging configurations.

The Subject FITBONE® TAA09 nail model is fixed to the bone by Locking Screws, made from Stainless steel AISI 316LVM, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)".

Surgical procedures with the use of the Subject FITBONE® TAA09 model shall be performed with the support of orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The surgical instruments offered by WITTENSTEIN intens GmbH as part of this submission under product code: LXH (21 CFR 888.4540).

The orthopedic instruments are made by medical grade stainless steel, Aluminum and Silicone.

The Subject FITBONE® TAA09 and the Subject external electronic controlling components are designed to be used in the operating theatre and home environment.

AI/ML Overview

The FITBONE® TAA intramedullary lengthening system is intended for limb lengthening of the femur and tibia. It is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device (FITBONE® TAA, K163368) and other similar devices, rather than establishing specific, quantified acceptance criteria for a new clinical performance study. The "Performance Analysis" section summarizes that the device performs "as well as or better than the predicate devices" based on various testing.

Therefore, the table below reflects what can be inferred as "acceptance criteria" based on the substantial equivalence argument, which inherently means meeting or exceeding the predicate's performance. Specific quantitative targets for clinical outcomes are not explicitly stated in this document.

Acceptance Criterion (Inferred from Substantial Equivalence to Predicate)	Reported Device Performance
Mechanical Performance: Biomechanical integrity (e.g., strength, durability, fatigue resistance) equivalent to or better than the predicate device.	"Results to support the determination of substantial equivalence from engineering, electrical, bench, human factors testing... confirm that Subject devices are as safe, as effective, and performs as well as or better than the predicate devices." (Implies successful completion of relevant mechanical tests)
Material Compatibility: Use of biocompatible materials equivalent to the predicate device.	"Material: are equivalent as the primary predicate." (Specifically mentions Stainless steel AISI 316LVM, according to ASTM F138-13)
Sterilization Efficacy: Sterilization method and effectiveness equivalent to the predicate device.	"Sterilization: identical method as the FITBONE® TAA- K163368."
Functional Equivalence: Powering, elongation, and control mechanisms are equivalent to or improve upon the predicate device's functionality.	"The Subject FITBONE® TAA09 intramedullary lengthening nail elongation is propelled by a highly sensitive gear and spindle mechanism which converts the rotation of the motor into an axial movement with high force." "The energy needed for the distraction process of the nail is transmitted from the outside by placing the external Transmitter over the implanted Receiver..." (These describe the mechanism, equivalent to the predicate.)
Safety: No new or unresolved risks compared to the predicate device.	"No new risks associated to the Subject device compared to those of the additional predicate and the reference devices which have similar indications for use, anatomical sites and conditions of use." "Any potential hazards of the changes introduced... have been evaluated and controlled through Risk Management activities."
Intended Use & Indications: Identical to the predicate device.	"Intended use: identical to FITBONE® TAA K163368 and additional predicate" and "Indications for Use, Anatomical sites, operating principles and conditions of use are substantially equivalent to FITBONE® TAA K163368 and to the additional predicate."

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

The document describes non-clinical performance data, specifically engineering, electrical, bench, and human factors testing. It does not mention a test set from a clinical study with human subjects.

Sample Size: Not applicable as no clinical test set is described. The performance assessment relies on engineering and bench testing, for which sample sizes (e.g., number of nails tested for fatigue) are not specified in this summary.
Data Provenance: Not applicable as no clinical data (e.g., country of origin, retrospective/prospective) is associated with a "test set" in the context of this 510(k) summary. The testing appears to have been conducted by the manufacturer, WITTENSTEIN intens GmbH.

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

This information is not provided in the document. As no clinical "test set" is described for algorithm evaluation, the concept of establishing ground truth by experts is not applicable to the data presented. The "ground truth" for the engineering and bench testing would be defined by established standards and internal validation protocols.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable as no clinical "test set" requiring expert adjudication is described in the document.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The submission is based on engineering, electrical, bench, and human factors testing to demonstrate substantial equivalence to a predicate device, not on a clinical effectiveness study involving human readers or AI assistance.

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

This is not applicable. The device, FITBONE® TAA, is an intramedullary lengthening system, a physical medical device, not an AI algorithm or software device. Therefore, a "standalone algorithm performance" study is not relevant.

7. The Type of Ground Truth Used

The "ground truth" in this submission is established through:

Engineering Standards and Bench Testing Results: Compliance with established mechanical, material, and electrical performance standards (e.g., ASTM F138-13 for stainless steel). The performance of the predicate device also serves as a benchmark for equivalence.
Risk Management Activities: Identification and control of potential hazards.
Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (FITBONE® TAA, K163368) forms the basis for demonstrating substantial equivalence.

No pathology, expert consensus, or outcomes data from a new clinical study are used as ground truth for a test set in this 510(k) summary.

8. The Sample Size for the Training Set

This information is not applicable. The FITBONE® TAA is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The design and development of the device would involve engineering principles and prototypes, but not a data-based "training set."

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

This information is not applicable as there is no "training set" in the context of this medical device submission.

Summary

{0}------------------------------------------------

February 17, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font and enclosed in a blue square.

WITTENSTEIN intens GmbH % Cheryl Wagoner Consultant Wagoner Consulting LLG P O Box 15729 Wilmington, North Carolina 28408

Re: K203399

Trade/Device Name: FITBONE® TAA Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: November 16, 2020 Received: November 19, 2020

Dear Cheryl Wagoner:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K203399

Device Name FITBONE® TAA

Indications for Use (Describe)

The WITTENSTEIN intens GmbH FITBONE® TAA intramedullary lengthening system is intended for limb lengthening of the femur and tibia.

The FITBONE®TA A intramedullary lengthening system is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.

Type of Use (Select one or both, as applicable):

☑
☐

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) SUMMARY

Submitter information

Company Name:	WITTENSTEIN intens GmbH
Address	Walter-Wittenstein-Strasse 197999 Igersheim, Germany
Telephone	+49 7931 493 0
Fax	+49 7931 493 10906

Contact Person	Hartmut KampaGeneral Manager
Address	Walter-Wittenstein-Strasse 197999 Igersheim, Germany
Telephone	+49 7931 493 10690
Fax	+49 7931 493 710690
Email address	hartmut.kampa@wittenstein.de
Date of submission	November 18, 2020

Trade Name. Common Name. Classification

Trade Name:	FITBONE® TAA
Common Name:	Rod, Fixation, Intramedullary and Accessories
Classification Name:	Intramedullary fixation rod
Regulation Number:	21 CFR 888.3020
Product Code:	HSB
Classification:	Class II
Panel code:	Orthopedic

Predicate devices and reference devices

Primary Predicate	510(k) Number	Manufacturer
FITBONE® TAA	K163368	WITTENSTEIN intens GmbH
Additional Predicate
PRECICE® Intramedullary LimbLengthening System	K133289 K131677	Ellipse Technologies (now:NuVasive SpecializedOrthopedics Inc.)
Reference Devices
Fassier Duval Telescopic IM NailSystem	K020885	Pega Medical, Inc.
PRECICE® Plating System	K192181	NuVasive SpecializedOrthopedics Inc.

Device description	The FITBONE® TAA System is a fully implantable intramedullary lengthening device. Changes to the existing FITBONE® TAA (K163368) have been introduced to extend the current portfolio by new Subject
--------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

{4}------------------------------------------------

Indications for use
FITBONE® TAA09 intramedullary lengthening nail model fixed to the bone by new Subject Locking Screws and a new Subject Receiver connected to the Subject nail by a bipolar feed line with new Subject external Retraction Control Set consisting of a control electronics with a Retraction Transmitter. New Subject surgical tools are provided to facilitate the surgical process.The Subject FITBONE® TAA09 intramedullary lengthening nail model, line extension of the primary predicate FITBONE® TAA (Κ163368) models is implanted into the medullary canal of the femur or tibia. The nail is fixed to the bone by Locking Screws through longitudinal openings in the nail.The Subject FITBONE® TAA09 intramedullary lengthening nail consists of a telescoping system that allows it to expand. It is powered by hermetically enclosed electromagnetic motor which draws the telescope apart, during which the extension is externally steered via electronic impulses. The Subject FITBONE® TAA09 intramedullary lengthening nail elongation is propelled by a highly sensitive gear and spindle mechanism which converts the rotation of the motor into an axial movement with high force.The energy needed for the distraction process of the nail is transmitted from the outside by placing the external Transmitter over the implanted Receiver which is placed in the subcutaneous tissue during FITBONE® surgery. The energy transmission will be triggered by pressing the "Patient" button on the control electronics by the patient. There is no transcutaneous contact between the implanted intramedullary nail and the outer surface of the patient's body.The nail and Receiver are offered in sterile conditions and the Locking screws and non-implantable external electronic controlling components in non-sterile packaging configurations.The Subject FITBONE® TAA09 nail model is fixed to the bone by Locking Screws, made from Stainless steel AISI 316LVM, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)".Surgical procedures with the use of the Subject FITBONE® TAA09 model shall be performed with the support of orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The surgical instruments offered by WITTENSTEIN intens GmbH as part of this submission under product code: LXH (21 CFR 888.4540).The orthopedic instruments are made by medical grade stainless steel, Aluminum and Silicone.The Subject FITBONE® TAA09 and the Subject external electronic controlling components are designed to be used in the operating theatre and home environment.The WITTENSTEIN intens GmbH FITBONE® TAA intramedullary lengthening system is intended for limb lengthening of the femur and tibia.

Indications for use

FITBONE® TAA09 intramedullary lengthening nail model fixed to the bone by new Subject Locking Screws and a new Subject Receiver connected to the Subject nail by a bipolar feed line with new Subject external Retraction Control Set consisting of a control electronics with a Retraction Transmitter. New Subject surgical tools are provided to facilitate the surgical process.The Subject FITBONE® TAA09 intramedullary lengthening nail model, line extension of the primary predicate FITBONE® TAA (Κ163368) models is implanted into the medullary canal of the femur or tibia. The nail is fixed to the bone by Locking Screws through longitudinal openings in the nail.The Subject FITBONE® TAA09 intramedullary lengthening nail consists of a telescoping system that allows it to expand. It is powered by hermetically enclosed electromagnetic motor which draws the telescope apart, during which the extension is externally steered via electronic impulses. The Subject FITBONE® TAA09 intramedullary lengthening nail elongation is propelled by a highly sensitive gear and spindle mechanism which converts the rotation of the motor into an axial movement with high force.The energy needed for the distraction process of the nail is transmitted from the outside by placing the external Transmitter over the implanted Receiver which is placed in the subcutaneous tissue during FITBONE® surgery. The energy transmission will be triggered by pressing the "Patient" button on the control electronics by the patient. There is no transcutaneous contact between the implanted intramedullary nail and the outer surface of the patient's body.The nail and Receiver are offered in sterile conditions and the Locking screws and non-implantable external electronic controlling components in non-sterile packaging configurations.The Subject FITBONE® TAA09 nail model is fixed to the bone by Locking Screws, made from Stainless steel AISI 316LVM, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)".Surgical procedures with the use of the Subject FITBONE® TAA09 model shall be performed with the support of orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The surgical instruments offered by WITTENSTEIN intens GmbH as part of this submission under product code: LXH (21 CFR 888.4540).The orthopedic instruments are made by medical grade stainless steel, Aluminum and Silicone.The Subject FITBONE® TAA09 and the Subject external electronic controlling components are designed to be used in the operating theatre and home environment.The WITTENSTEIN intens GmbH FITBONE® TAA intramedullary lengthening system is intended for limb lengthening of the femur and tibia.

{5}------------------------------------------------

	The FITBONE®TAA intramedullary lengthening system is indicated foradult and pediatric (greater than 12 through 21 years of age) patients.
TechnologicalCharacteristics	The Subject device fundamental scientific principles and technologicalcharacteristic, including: the intended use, material and general design,are the same as, or similar to, FITBONE® TAA - K163368 and thechosen additional predicate device.Summary of the technological characteristics:✓ Intended use: identical to FITBONE® TAA K163368 and additional predicate✓ Indications for Use, Anatomical sites, operating principles andconditions of use are substantially equivalent to FITBONE® TAAK163368 and to the additional predicate. No new risks associatedto the Subject device compared to those of the additional predicateand the reference devices which have similar indications for use,anatomical sites and conditions of use. Verification activities onSubject devices demonstrated the same safety and effectivenessperforms equivalent to the predicate devices.✓ Material: are equivalent as the primary predicate.✓ Geometry and size: similar sizes and geometry of the nails; similarsizes and geometry of the Locking Screws.✓ Sterilization: identical method as the FITBONE® TAA- K163368.The technological characteristics of the Subjects FITBONE® TAA aresubstantially equivalent to the FITBONE® TAA K163368 and predicate device.
PerformanceAnalysis	Subject devices have similar configuration, material, sizes and designas to FITBONE® TAA K163368 and the predicate device.Results to support the determination of substantial equivalence fromengineering, electrical, bench, human factors testing of the Subjectdevices, confirm that Subject devices are as safe, as effective, andperforms as well as or better than the predicate devices.Any potential hazards of the changes introduced to FITBONE® TAAK163368 have been evaluated and controlled through RiskManagement activities, and any relevant information, have beenaddressed in the labelling, after all control measures have beenimplemented.
Conclusion	Based upon equivalences in: intended use, patient population, site ofapplication, conditions of use, operating principles, and the non-clinicalperformance data, the changes introduced in the FITBONE® TAA(K163368) for the new model FITBONE® TAA09 Subject nail and theadditional Subject components have been shown to be safe andeffective and to perform equivalently as compared to the legallymarketed predicate devices.Therefore, the changes to FITBONE® TAA (K163368) for Subjectdevices are substantially equivalent to the legally marketed predicate devices.

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.