(90 days)
No
The description focuses on mechanical and electronic components for controlled lengthening, with no mention of AI/ML for decision-making, analysis, or control.
Yes
Explanation: The device is intended for limb lengthening, which is a therapeutic intervention aimed at treating a medical condition (shortened limbs) and improving the patient's body function.
No
This device is an intramedullary lengthening system designed for limb lengthening of the femur and tibia, not for diagnosing medical conditions.
No
The device description clearly outlines multiple hardware components including an implantable intramedullary nail, locking screws, a receiver, an external transmitter, control electronics, and surgical tools. While there are electronic and control components, the core of the device is a mechanical and electrical system for limb lengthening, not solely software.
Based on the provided text, the WITTENSTEIN intens GmbH FITBONE® TAA intramedullary lengthening system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "limb lengthening of the femur and tibia." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an "implantable intramedullary lengthening device" that is surgically placed inside the bone. It uses mechanical and electrical components to achieve lengthening.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
The FITBONE® TAA system is a therapeutic device used for a surgical intervention, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
HSB
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur and tibia
Indicated Patient Age Range
adult and pediatric (greater than 12 through 21 years of age) patients
Intended User / Care Setting
operating theatre and home environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Results to support the determination of substantial equivalence from engineering, electrical, bench, human factors testing of the Subject devices, confirm that Subject devices are as safe, as effective, and performs as well as or better than the predicate devices. Any potential hazards of the changes introduced to FITBONE® TAA K163368 have been evaluated and controlled through Risk Management activities, and any relevant information, have been addressed in the labelling, after all control measures have been implemented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 1 |
| 97999 Igersheim, Germany | |
| Telephone | +49 7931 493 0 |
| Fax | +49 7931 493 10906 |
| Contact Person | Hartmut Kampa
General Manager |
|--------------------|----------------------------------------------------------|
| Address | Walter-Wittenstein-Strasse 1
97999 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 Limb | ||
| Lengthening System | K133289 | |
| K131677 | Ellipse Technologies (now: | |
| NuVasive Specialized | ||
| Orthopedics Inc.) | ||
| Reference Devices | ||
| Fassier Duval Telescopic IM Nail | ||
| System | K020885 | Pega Medical, Inc. |
| PRECICE® Plating System | K192181 | NuVasive Specialized |
| Orthopedics 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. |
5
| | The FITBONE®TAA intramedullary lengthening system is indicated for
adult and pediatric (greater than 12 through 21 years of age) patients. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The Subject device fundamental scientific principles and technological
characteristic, including: the intended use, material and general design,
are the same as, or similar to, FITBONE® TAA - K163368 and the
chosen 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 and
conditions of use are substantially equivalent to FITBONE® TAA
K163368 and to the additional predicate. 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. Verification activities on
Subject devices demonstrated the same safety and effectiveness
performs equivalent to the predicate devices.
✓ Material: are equivalent as the primary predicate.
✓ Geometry and size: similar sizes and geometry of the nails; similar
sizes and geometry of the Locking Screws.
✓ Sterilization: identical method as the FITBONE® TAA- K163368.
The technological characteristics of the Subjects FITBONE® TAA are
substantially equivalent to the FITBONE® TAA K163368 and predicate device. |
| Performance
Analysis | Subject devices have similar configuration, material, sizes and design
as to FITBONE® TAA K163368 and the predicate device.
Results to support the determination of substantial equivalence from
engineering, electrical, bench, human factors testing of the Subject
devices, confirm that Subject devices are as safe, as effective, and
performs as well as or better than the predicate devices.
Any potential hazards of the changes introduced to FITBONE® TAA
K163368 have been evaluated and controlled through Risk
Management activities, and any relevant information, have been
addressed in the labelling, after all control measures have been
implemented. |
| Conclusion | Based upon equivalences in: intended use, patient population, site of
application, conditions of use, operating principles, and the non-clinical
performance data, the changes introduced in the FITBONE® TAA
(K163368) for the new model FITBONE® TAA09 Subject nail and the
additional Subject components have been shown to be safe and
effective and to perform equivalently as compared to the legally
marketed predicate devices.
Therefore, the changes to FITBONE® TAA (K163368) for Subject
devices are substantially equivalent to the legally marketed predicate devices. |