(228 days)
Not Found
No
The summary describes a mechanical external fixation system with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "treatment of bone conditions," which is a therapeutic purpose.
No
The device description and intended use clearly state that the Integra External Fixation System is a modular external fixator used to treat bone conditions, perform corrections, and reconstruct bones, rather than to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly lists physical components like rings, foot plates, screws, wires, rods, nuts, bolts, clamps, and special instruments, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Integra External Fixation System is a physical device used externally on the body to stabilize and treat bone conditions. It consists of mechanical components like rings, screws, and rods.
- Intended Use: The intended use clearly describes a surgical/orthopedic procedure involving the physical manipulation and stabilization of bones.
The device's function and application are entirely external to the body and do not involve testing biological samples.
N/A
Intended Use / Indications for Use
The Integra External Fixation System is an external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. Additional indications for the Integra External Fixation System include:
- Correction of deformity
- Revision procedures where other treatments or devices have been unsuccessful
- Bone reconstruction procedures
- Fusions and replantations of the foot
- Charcot reconstruction and Lisfranc dislocations
- Ankle distraction (arthrodiastasis)
Product codes
KTT
Device Description
The Integra® External Fixation System is a single-use modular external fixator consisting of the following components: rings, foot plates, compression/distraction struts, half-pin bone screws, straight/olive wires, rods, nuts, bolts, clamps, and other modular fixator components. Special instruments (e.g. wrenches) are required for proper assembly of the apparatus. Adjustment of the fixator is possible during the course of treatment. When properly used by an experienced clinician, the Integra External Fixation System may preserve limb function by minimizing operative trauma to anatomical structures and preserving blood supply.
Implants:
Half-pin Bone Screws
The self-drilling half-pin bone screw is 200mm in length and offered in the following sizes: 4mm diameter w/ 20mm thread length, 4mm diameter w/ 30mm thread length, 4mm diameter w/ 40mm thread length, 5mm diameter w/ 30mm thread length. 5mm diameter w/ 40mm thread length. 5mm diameter w/ 50mm thread length, 6mm diameter w/ 30mm thread length, 6mm diameter w/ 40mm thread length, and 6mm diameter w/ 50mm thread length.
K-wires
The wires are offered in the following sizes: 400mm smooth, 400mm olive, and 530mm olive. K-wire washer in 1 size
Single Use Components:
Rings
Full Ring- The full ring is offered in the following sizes: 140mm, 160mm, 180mm, and 200mm.
Half Ring- The half ring is offered in the following sizes: 140mm, 160mm, 180mm, 200mm, and 220mm.
5/8" Ring- The 5/8" ring is offered in the following sizes: 140mm, 160mm, 180mm, 200mm, and 220mm.
Cross bar - Two lengths
Foot Plates
The foot plate is offered in the following sizes: 140mm, 160mm, and 180mm.
Struts
Struts are offered in the following lengths: long (180-230mm), medium (140-180mm), and short (95-140mm).
Rocker bottom
K-wire holding bolts
Half pin clamps
Extensions:
Threaded rods (20mm through 200mm, hex posts (20mm through 60mm), cubes (1, 2, 3, and 4 hole)
Miscellaneous components:
Washers, nuts, bolts (10mm through 18mm), universal joint, slotted posts ( small and large), and plates ( straight and twisted).
Reusable Instruments: Wire tensioner Wrenches Wire cutters Wire Benders AO adapters Holding and alignment Blocks Drill guide assembly Drills Provisional Alignment Guides
Materials:
The implants in the Integra External Fixation system are half-pin bone screws and wires and are manufactured from 316L ASTM F138 stainless steel. The rings and footplates are manufactured from anodized aluminum alloy. The wire/half-pin bone screw stopper coin is manufactured from silicone rubber. The rockerbottom frame component is manufactured from Radel plastic, aluminum, and silicone rubber. The reusable instrumentation is manufactured from biocompatible materials, including stainless steel, aluminum, and carbide tips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones, limb, foot, ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
experienced clinician
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)
The performance of the Integra External Fixation System was verified to be statistically equivalent to that of the predicate device. The predicate construct and Integra External Fixation System construct were tested both dynamically and statically. The stiffness of the 2 systems was compared and was statistically equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a bird in flight, formed by three stylized human profiles facing to the right. The profiles are layered, creating a sense of depth and movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 10, 2014
Ascension Orthopedics % Mr. Steven Brown IMDS 560 West Golf Course Road Providence, Utah 84332
Re: K140463 Trade/Device Name: Integra External Fixation 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: September 12, 2014 Received: September 15, 2014
Dear Mr. Brown:
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
1
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 3: INDICATIONS FOR USE
510(k) Number (if known): K140463 Device Name: Integra External Fixation System Indications for Use: INDICATIONS FOR USE
The Integra External Fixation System is an external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. Additional indications for the Integra External Fixation System include:
- Correction of deformity
- Revision procedures where other treatments or devices have been unsuccessful
- Bone reconstruction procedures
- Fusions and replantations of the foot
- · Charcot reconstruction and Lisfranc dislocations
- · Ankle distraction (arthrodiastasis)
AND/OR Prescription Use Over-the-Counter Use (21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation
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Section 4: 510(k) SUMMARY
Device Trade Name: Integra External Fixation System
Date: October 1, 2014
Sponsor:
Integra LifeSciences Corporation
Contact Person:
Integra Life Sciences Corp Frederic Testa Director, Regulatory Affairs 311 Enterprise Drive Plainsboro, NJ 08536 609-936-3630 frederic.testa@integralife.com
Manufacturer:
Ascension Orthopedics 8700 Cameron Road, Suite 100 Austin, TX 78754 609-936-3630 frederic.testa@integralife.com
| Common Name: | External Fixation Device |
|---|---|
| Device Classification: | Class II |
| Classification Name: | Single/multiple component metallic bone fixation appliances and |
| accessories (21 CFR 888.3030) | |
| Regulation: | 21 CFR 888.3030, Single/multiple component metallic bone |
| fixation appliances and accessories | |
| Device Regulation Panel: | Orthopedic |
Device Product Code: Orthopedic KTT
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Device Description:
The Integra® External Fixation System is a single-use modular external fixator consisting of the following components: rings, foot plates, compression/distraction struts, half-pin bone screws, straight/olive wires, rods, nuts, bolts, clamps, and other modular fixator components. Special instruments (e.g. wrenches) are required for proper assembly of the apparatus. Adjustment of the fixator is possible during the course of treatment. When properly used by an experienced clinician, the Integra External Fixation System may preserve limb function by minimizing operative trauma to anatomical structures and preserving blood supply.
Implants:
Half-pin Bone Screws
The self-drilling half-pin bone screw is 200mm in length and offered in the following sizes: 4mm diameter w/ 20mm thread length, 4mm diameter w/ 30mm thread length, 4mm diameter w/ 40mm thread length, 5mm diameter w/ 30mm thread length. 5mm diameter w/ 40mm thread length. 5mm diameter w/ 50mm thread length, 6mm diameter w/ 30mm thread length, 6mm diameter w/ 40mm thread length, and 6mm diameter w/ 50mm thread length.
K-wires
The wires are offered in the following sizes: 400mm smooth, 400mm olive, and 530mm olive. K-wire washer in 1 size
Single Use Components:
Rings
Full Ring- The full ring is offered in the following sizes: 140mm, 160mm, 180mm, and 200mm.
Half Ring- The half ring is offered in the following sizes: 140mm, 160mm, 180mm, 200mm, and 220mm.
5/8" Ring- The 5/8" ring is offered in the following sizes: 140mm, 160mm, 180mm, 200mm, and 220mm.
Cross bar - Two lengths
Foot Plates
The foot plate is offered in the following sizes: 140mm, 160mm, and 180mm.
Struts
Struts are offered in the following lengths: long (180-230mm), medium (140-180mm), and short (95-140mm).
Rocker bottom
K-wire holding bolts
Half pin clamps
Extensions:
Threaded rods (20mm through 200mm, hex posts (20mm through 60mm), cubes (1, 2, 3, and 4 hole)
Miscellaneous components:
Washers, nuts, bolts (10mm through 18mm), universal joint, slotted posts ( small and large), and plates ( straight and twisted).
5
Reusable Instruments: Wire tensioner Wrenches Wire cutters Wire Benders AO adapters Holding and alignment Blocks Drill guide assembly Drills Provisional Alignment Guides
Materials:
The implants in the Integra External Fixation system are half-pin bone screws and wires and are manufactured from 316L ASTM F138 stainless steel. The rings and footplates are manufactured from anodized aluminum alloy. The wire/half-pin bone screw stopper coin is manufactured from silicone rubber. The rockerbottom frame component is manufactured from Radel plastic, aluminum, and silicone rubber. The reusable instrumentation is manufactured from biocompatible materials, including stainless steel, aluminum, and carbide tips.
Intended Use:
The Integra® External Fixation System is a single-use modular external fixator consisting of rings, half-pin bone screws, wires, and struts and is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Indications for Use:
The Integra External Fixation System is an external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. Additional indications for the Integra External Fixation System include:
- Correction of deformity
- Revision procedures where other treatments or devices have been unsuccessful
- Bone reconstruction procedures
- · Fusions and replantations of the foot
- Charcot reconstruction and Lisfranc dislocations
- Ankle distraction (arthrodiastasis)
Technological Characteristics:
There are no technological characteristics that raise new issues of safety or effectiveness.
Assessment of performance data:
The performance of the Integra External Fixation System was verified to be statistically equivalent to that of the predicate device. The predicate construct and Integra External Fixation System construct were tested both dynamically and statically. The stiffness of the 2 systems was
6
compared and was statistically equivalent. A summary of the objective, acceptance criteria, results, and conclusions, as well as the detailed test reports can be found in Section 36.
Legally Marketed Predicate Device:
Biomet® Vision™ FootRing™ System (K093057)
Predicate Indications for Use:
The Biomet® Vision™ FootRing™ System ( K093057) is indicated for
-
- Leg lengthening;
-
- Osteotomies;
-
- Joint arthrodesis;
-
- Fracture fixations:
-
- Other bone conditions amenable to treatment by the use of external fixation treatment modality:
-
- Correction of deformity;
-
- Revision procedure where other treatments or devices have been unsuccessful;
-
- Bone reconstruction procedures;
-
- Fusions and replantations of the foot
-
- Charcot foot reconstruction and Lisfranc dislocation;
-
- Ankle distraction (arthrodastasis);
Purpose:
The purpose of this Traditional 510(k) submission is to gain clearance for the Integra External Fixation System.
Based upon the similarities of the Integra External Fixation System and the predicate devices studied, the safety and effectiveness of the Integra External Fixation System is substantially equivalent to the predicate devices referenced.