DEPUY SYNTHES MAXFRAME AUTOSTRUT System
Device Facts
| Record ID | K231922 |
|---|---|
| Device Name | DEPUY SYNTHES MAXFRAME AUTOSTRUT System |
| Applicant | DePuy Synthes |
| Product Code | KTT · Orthopedic |
| Decision Date | Jul 26, 2023 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The MAXFRAME AUTOSTRUT System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused or will not be crossed with hardware: • fracture fixation (open and closed) • pseudoarthrosis of long bones • limb lengthening (epiphyseal or metaphyseal distraction) • joint arthrodesis • infected fractures or nonunions • correction of bony or soft tissue deformities • correction of segmental defects.
Device Story
External fixation system for orthopedic correction; comprises control system, software, and six motor-powered, length-adjustable hexapod struts. Used with MAXFRAME multi-axial correction system. Struts are telescopic rods (stainless steel/aluminum) with polymeric motor adapter. Provided sterile. System automates distraction/correction processes previously performed manually. Healthcare providers use the control system and software to manage strut adjustments; output facilitates precise bone segment manipulation for limb lengthening or deformity correction. Benefits include controlled, automated mechanical distraction to promote bone healing and alignment.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by bench testing, including mechanical testing, shelf-life validation, packaging validation, sterilization validation, and biocompatibility evaluation.
Technological Characteristics
External fixation system; six motor-powered, length-adjustable hexapod struts. Materials: stainless steel, aluminum, and polymeric motor adapter. Sterilization: ethylene oxide. Connectivity: integrates with MAXFRAME multi-axial correction system (K161417). Software: previously cleared under K202810.
Indications for Use
Indicated for adults, children (3-12), and adolescents (12-21) with fused growth plates or where hardware does not cross growth plates for fracture fixation, pseudoarthrosis, limb lengthening, joint arthrodesis, infected fractures/nonunions, and correction of bony/soft tissue deformities or segmental defects.
Regulatory Classification
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.
Predicate Devices
- AutoStrut G2 (K202810)
Reference Devices
- MAXFRAME multi axial correction system (K161417)
Submission Summary (Full Text)
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July 26, 2023
Depuy Synthes Mitchel Bartko Regulatory Affairs Specialist III 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K231922
Trade/Device Name: DEPUY SYNTHES MAXFRAME AUTOSTRUT System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: June 29, 2023 Received: June 29, 2023
Dear Mitchel Bartko:
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.
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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 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.
# Lixin Liu -S
Lixin Liu, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known) K231922
Device Name
DEPUY SYNTHES MAXFRAME AUTOSTRUT System
Indications for Use (Describe)
The MAXFRAME AUTOSTRUT System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused or will not be crossed with hardware:
- · fracture fixation (open and closed)
- · pseudoarthrosis of long bones
- · limb lengthening (epiphyseal or metaphyseal distraction)
- · joint arthrodesis
- · infected fractures or nonunions
- correction of bony or soft tissue deformities
- · correction of segmental defects.
| 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)
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## 510(k) Summary
| Sponsor | DePuy Synthes | Address |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Primary Contact | Mitchel Bartko<br>Regulatory Affairs Specialist III<br>DePuy Synthes | 1301 Goshen Parkway<br>West Chester, PA USA<br>T: 908-808-6541<br>Email: mbartko1@its.jnj.com |
| Secondary Contact | Silvia De La Barra<br>Manager, Regulatory Affairs<br>DePuy Synthes | 1301 Goshen Parkway<br>West Chester, PA USA<br>T: 385-258-9397<br>Email: sdelabar@its.jnj.com |
| Date Prepared | June 29, 2023 | |
| Device Trade Name | DEPUY SYNTHES MAXFRAME AUTOSTRUT System | |
| Common Name | External Fixation System | |
| Classification | Class II | |
| Product Code | KTT (Appliance, fixation, nail/blade/plate combination, multiple components) | |
| Regulation Number | 888.3030 : Single/multiple component metallic bone fixation appliances and<br>accessories | |
| Predicate Device(s) | K202810 - Autostrut G2 | |
| Device Description<br>Summary | The MAXFRAME AUTOSTRUT System is comprised of a control system,<br>software, and six length-adjustable struts powered by a motor. The devices are<br>used in conjunction with the DePuy Synthes MAXFRAME multi axial<br>correction system (K161417), including all its parts and software, except that the<br>MAXFRAME struts are substituted with the MAXFRAME AUTOSTRUT<br>Hexapod Struts.<br>This submission is solely for the clearance of a sterile version of the<br>MAXFRAME AUTOSTRUT Hexapod Struts. The MAXFRAME<br>AUTOSTRUT Hexapod Struts are provided sterile and are comprised of<br>telescopic rods made of stainless steel and aluminum and a motor adapter made<br>from polymeric material. The MAXFRAME AUTOSTRUT Hexapod Struts are<br>available in three lengths - short, medium, and long.<br>The MAXFRAME AUTOSTRUT Control System and Software have been<br>cleared under K202810. | |
| Intended Use | | |
| Indications for Use | The MAXFRAME AUTOSTRUT System is indicated for the following<br>treatments in adults, and in both children (3-12) and adolescents (12-21) in<br>which growth plates have fused or will not be crossed with hardware:<br>• fracture fixation (open and closed)<br>• pseudoarthrosis of long bones<br>• limb lengthening (epiphyseal or metaphyseal distraction)<br>• joint arthrodesis<br>• infected fractures or nonunions<br>• correction of bony or soft tissue deformities<br>• correction of segmental defects. | |
| Indications for Use<br>Comparison | The MAXFRAME AUTOSTRUT System has the same indications for use as the<br>predicate device (AutoStrut G2 [K202810]). | |
| Technological<br>Comparison | The DePuy Synthes MAXFRAME AUTOSTRUT System has similar<br>technological characteristics (design, material and chemical composition) as the<br>predicate device AutoStrut G2 (K202810). The only differences between the<br>predicate and subject device is that the subject device struts are provided<br>ethylene oxide sterilized and packaged within sterile barrier packaging. The<br>predicate device struts are provided non-sterile and are end user steam sterilized. | |
| Non-clinical<br>Performance<br>Testing | Non-Clinical Performance Testing was performed and included Mechanical<br>Testing, Shelf-Life Validation, Packaging Validation, Sterilization Validation<br>and Biocompatibility Evaluation. The data was used for the determination of<br>substantial equivalence. | |
| Clinical<br>Performance Data | Clinical Performance Data was not necessary for the determination of substantial<br>equivalence. | |
| Conclusion | These minor differences in the technological characteristics compared to the<br>predicate do not raise different questions of safety or effectiveness. Bench<br>testing demonstrates that the sterile MaxFrame AutoStrut Hexapod Strut is as<br>safe and effective as its predicate device. Therefore, MaxFrame AutoStrut<br>System is substantially equivalent to its predicate.<br>The purpose of this 510(k) submission is to clear the sterile version of the<br>MAXFRAME AUTOSTRUT Hexapod Strut only. The MAXFRAME<br>AUTOSTRUT Control System and Software have been cleared under K202810. | |
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