Who is the manufacturer of Sequel External Fixation Device?

Sequel Medical, Inc. filed the 510(k) submission for Sequel External Fixation Device (K202833).

What is the FDA product code for Sequel External Fixation Device?

KTT. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Sequel External Fixation Device?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Sequel External Fixation Device?

Pitkar External Fixation System (K190486); SBi RingFIXTM System (K071394); Orthofix TrueLok Hexapod System (TL-HEX) V2.0 (K170650).

Who can help prepare an FDA 510(k) submission like Sequel External Fixation Device?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Sequel External Fixation Device

K202833 · Sequel Medical, Inc. · KTT · Jan 19, 2021 · Orthopedic

Device Facts

Record ID	K202833
Device Name	Sequel External Fixation Device
Applicant	Sequel Medical, Inc.
Product Code	KTT · Orthopedic
Decision Date	Jan 19, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

The Sequel® External Fixation System is indicated for both adult and pediatric patients for: 1. Open and closed fracture fixation 2. Pseudoarthrosis or non-union of long bones 3. Limb lengthening by epiphyseal or metaphyseal distraction 4. Correction of bony or soft tissue deformities 5. Correction of segmental or nonsegmental bony or soft tissue defects 6. Post-Traumatic joint contracture which has resulted in loss of range of motion

Device Story

Sequel External Fixation System is a modular, single-use external fixator; components include implantable half pins, fixation wires, rings, struts, telescoping/threaded rods, hinges, and connection plates. Healthcare professionals assemble frame configurations based on patient anatomy and clinical needs. Operates via Ilizarov apparatus method for distraction osteogenesis. Used in clinical settings for fracture stabilization and orthopedic correction. Output is a mechanical support frame providing structural stability to bone segments. Benefits include bone healing, deformity correction, and restoration of joint range of motion. Components are manufactured from titanium, stainless steel, and aluminum; supplied non-sterile for autoclave sterilization by the institution.

Clinical Evidence

No clinical data. Bench testing only, performed in accordance with ASTM F1541-17. Sterilization validated per ISO 17665-1 and ISO/TS 17665-2.

Technological Characteristics

Modular external fixator; materials: titanium, stainless steel, aluminum. Sensing/actuation: mechanical distraction via Ilizarov apparatus method. Dimensions/form factor: modular components (rings, struts, rods). Connectivity: none. Sterilization: moist heat (autoclave). Software: none.

Indications for Use

Indicated for adult and pediatric patients requiring open/closed fracture fixation, treatment of pseudoarthrosis/non-union of long bones, limb lengthening via distraction, correction of bony/soft tissue deformities or defects, and treatment of post-traumatic joint contracture with loss of range of motion.

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

Pitkar External Fixation System (K190486)
SBi RingFIXTM System (K071394)
Orthofix TrueLok Hexapod System (TL-HEX) V2.0 (K170650)

Related Devices

K260073 — XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm · Biodynamik, Inc. · Feb 10, 2026
K160830 — Integra External Fixation System · Ascension Orthopedics · Jul 6, 2016
K253291 — Excelsior System · Blue Ocean Global · Jan 20, 2026
K113327 — HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM · Stryker Corp. · Mar 29, 2012
K181528 — Austin Miller Large External Fixation System · Austin Miller Trauma, LLC · Feb 28, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ January 19, 2021 Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side. Sequel Medical Inc. Valentina Kamysheva CEO 12550 Biscayne Blvd Ste 110 North Miami, Florida 33181-2536 Re: K202833 Trade/Device Name: Sequel External Fixation Device 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: October 23, 2020 Received: November 20, 2020 Dear Valentina Kamysheva: 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 mediation-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, Ting Song, Ph.D., R.A.C. 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) K202833 #### Device Name Sequel External Fixation Device Indications for Use (Describe) The Sequel Ring Fixation System is indicated for both adults and pediatric patients for: - 1. Open and closed fracture fixation - 2. Pseudoarthrosis or non-union of long bones - 3. Limb lengthening by epiphyseal or metaphyseal distraction - 4. Correction of bony or soft tissue deformities - 5. Correction of segmental or nonsegmental bony or soft tissue defects - 6. Post-Traumatic joint contracture which has resulted in loss of range of motion | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | ☑ Residential Use (A.R.S. §33-181 Sets Limits) | ☐ For The Operation of A.R.S. §33-181 Sets Limits) | |------------------------------------------------|----------------------------------------------------| |------------------------------------------------|----------------------------------------------------| > 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}------------------------------------------------ # K202833 - 510(K) SUMMARY In accordance with 21 CFR 807.92 the following information is provided for the Sequel External Fixation System 5110(k) premarket notification. ## 1. SUBMITTER | Applicant: | Sequel Medical 12550 Biscayne Blvd. Suite 110 Miami, Fl 33181 | |-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Valentina Kamysheva CEO Sequel Medical 12550 Biscayne Blvd. Suite 110 Miami, Fl 33181 Phone: 1-305-814-8299 Email: Valentina@sequelmd.com | | Date Prepared: | August 19, 2020 | ### 2. DEVICE | Name of Device: | Sequel External Fixation System | |-----------------------|-------------------------------------------------------------------------------------------------------| | Common or Usual Name: | Multilateral Fixator Components | | Regulatory Class: | II | | Product Code: | KTT- Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030) | | FDA Panel: | Division of Orthopedic Devices | Page 1 of 6 {4}------------------------------------------------ ### 3. PREDICATE DEVICES | Predicate Device: | K190486 Pitkar External Fixation System S H Pitkar Orthotools Pvt Ltd. Plot No. EL 32, J Block, MIDC Bhosari Pune, IN 411026 | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Secondary Predicate Devices: | K071394 SBi RingFIXTM System Small Bone Innovations Inc. 505 Park Ave., 14th Floor New York, NY 10022 K170650 Orthofix TrueLok Hexapod System (TL-HEX) V2.0 Orthofix Srl Via Delle Nazioni 9 Bussolengo, IT 37012 | # 4. GENERAL DESCRIPTION The Sequel® External Fixation System is a single-use modular external fixator consisting of implantable half pins and fixation wires and non-patient contact rings, struts, telescoping rods, threaded rods, posts, hinges, connection plates, twisted plates, threaded sockets, bolts, washers and nuts that are combined by the health care professional to construct different frame configurations based on patient anatomy and indicated use. The frame forms the support metalwork for the torsion wire used in fracture fixation and several other indications for long bone fixation procedures. The Subject device includes additional components (tabbed rings and struts) compared to the primary predicate. The tabbed rings and struts are substantially equivalent to the tabbed rings and struts in the secondary predicates. Special wrenches and accessories are included for the proper assembly of the components. The components of the frame are manufactured from titanium, stainless steel, and aluminum. {5}------------------------------------------------ ## K202833 Page 3 of 6 ### 5. INDICATION FOR USE STATEMENT The Sequel® External Fixation System is indicated for both adult and pediatric patients for: - 1. Open and closed fracture fixation - 2. Pseudoarthrosis or non-union of long bones - 3. Limb lengthening by epiphyseal or metaphyseal distraction - 4. Correction of bony or soft tissue deformities - 5. Correction of segmental or nonsegmental bony or soft tissue defects - 6. Post-Traumatic joint contracture which has resulted in loss of range of motion # 6. SUBSTANTIAL EQUIVALENCE #### Comparison of Intended Use: The intended use of the Sequel® External Fixation System is equivalent to the intended use for the primary predicate. The system is intended used to provide stabilization of open and/or closed unstable fractures and other indicated corrective procedures. #### Indications for Use: The indications for use of the Sequel® External Fixation System are equivalent to the indications for use cleared for the primary predicate. Like the primary predicate, the Sequel® External Fixation System indicated for both adult and pediatric patients for open and closed fracture fixation, pseudoarthrosis or non-union of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, correction of segmental or nonsegmental bony or soft tissue defects, and post-traumatic joint contracture which has resulted in loss of range of motion. ### Technology Comparisons: Table 1 below compares the key technological feature of the subject devices to the predicate devices. {6}------------------------------------------------ | | Subject Device | Primary Predicate | Secondary Predicate | Secondary Predicate | |--------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K202833 | K190486 | K071394 | K170650 | | Device Name | Sequel® External Fixation System | Pitkar External Fixation System | SBi RingFIXTM System | Orthofix TrueLok Hexapod System (TL- HEX) V2.0 | | Classification Regulation | Class II | Class II | Class II | Class II | | Classification Product Code | KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | | Subsequent Product Code | Not Applicable | JDW - Pin, Fixation, Threaded | Not Applicable | OSN: Software for Diagnosis/Treatment | | Operating Principle | Ilizarov Apparatus Method - Distraction - Osteogenesis | Ilizarov Apparatus Method - Distraction Osteogenesis | Ilizarov Apparatus Method - Distraction Osteogenesis | Ilizarov Apparatus Method - Distraction Osteogenesis | | Components | External Fixator Frame Components. Tabbed rings Tabbed Struts | External fixator components. NA NA | External fixator components. Tabbed rings NA | External fixator components. NA Tabbed Struts May be used with a web-based software component that is designed to be used to assist the physician in creating a patient adjustment schedule that assists in adjusting the six struts | | Materials of Construction | Titanium Stainless Steel Aluminum | Titanium Stainless Steel Aluminum | Aluminum | Aluminum | | Sterilization | Supplied non-sterile in a sterilization tray to be sterilized by moist heat (autoclave) prior to use. | Supplied non-sterile in a sterilization tray to be sterilized by moist heat (autoclave) prior to use. | Supplied non-sterile in a sterilization tray to be sterilized by moist heat (autoclave) prior to use. | Supplied non-sterile in a sterilization tray to be sterilized by moist heat (autoclave) prior to use. | ### Table 1: Technological Comparison {7}------------------------------------------------ # 7. PERFORMANCE TESTING ### Biocompatibility Testing: The components of the Sequel® External Fixation System frame are not in direct contact with patient tissue. The frame components are not within the scope of ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The frame components are manufactured from the same material, by an equivalent manufacturing process, and to the same dimensional specifications as the primary predicate. The tabbed rings and struts are manufactured from the same material, by an equivalent manufacturing process and to the same dimensional specifications as secondary predicates. Therefore, biocompatibility testing is not required to prove substantial equivalence of the subject device. Refer to Table 2. The implantable half pins and fixation wires are manufactured from 316L stainless steel a material routinely used in implantable medical devices. The components are made by an equivalent manufacturing process and to the same dimensional specifications as the predicate devices. Therefore, biocompatibility testing is not required to prove substantial equivalence of the subject device. Refer to Table 2. | | Patient Contact | Material of Construction | Manufacturing Process | Dimensional Specifications | Sterilization Method | |-----------------------------------|-----------------------------------------|-----------------------------|--------------------------|-------------------------------|-------------------------| | Frame Components | Same No Direct Patient Contact | Same | Equivalent | Same | Same (Moist Heat) | | Tabbed Rings and Tabbed Struts | Same No Direct Patient Contact | Same | Equivalent | Same | Same (Moist Heat) | | Half Pins | Same Implantable | Same | Equivalent | Same | Same (Moist Heat) | | Fixation Wires | Same Implantable | Same | Equivalent | Same | Same (Moist Heat) | Table 2 - Biocompatibility Evaluation Subject Device vs Predicates {8}------------------------------------------------ ### K202833 Page 6 of 6 #### Bench Testing Bench testing for the characterization of the design and mechanical function of Sequel® External Fixation System was performed in accordance with ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation. The Sequel® External Fixation System conformed to the requirements and specification of this standard. ### Sterilization Validation The Sequel® External Fixation System is provided non-sterile in a sterilization tray. The Instructions for Use Manual specifies moist heat (autoclave) sterilization cycle parameters for the health care institution to sterilize the device prior to use. The recommended sterilization cycle was validated in accordance with ISO 17665-1:2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices and ISO/TS 17665-2:2009 Sterilization of health care products -- Moist heat -- Part 2: Guidance on the application of ISO 17665-1 #### Animal Testing Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device. ### Clinical Testing Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device. ### 8. CONCLUSION The substantial equivalence information provided in this submission demonstrates that the subject device is substantially equivalent to the predicate devices in both indications for use and technological characteristics. The additional components compared to the primary predicate are substantially equivalent to the components in the secondary predicates. The addition of the new components does not raise new questions of safety or effectiveness. The performance test results demonstrate that the device continues to meet all the specifications and requirements that were met by the predicate devices. Therefore, the subject device can be found substantially equivalent to the predicate devices