(98 days)
Not Found
No
The device description and intended use focus on mechanical components and their function in spinal fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is a temporary implant intended to provide stabilization, aid in the repair of bone fractures, and is used in spinal reconstructive surgery and as an adjunct to spinal fusions, which are all therapeutic functions.
No
The device is an implant for temporary stabilization during solid bony fusion and repair of bone fractures, not for diagnosing conditions.
No
The device description clearly outlines physical components made of implantable grade materials (woven band, band clip, metal insert, tulip head, set screw) and describes mechanical testing performed on these components. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The RESPONSE BandLoc Spinal Fixation is a temporary implant used in orthopedic surgery to provide mechanical stabilization during bone fusion and fracture repair. It is physically implanted into the patient's body.
The description clearly indicates a surgical implant used for structural support within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RESPONSE BandLoc Spinal Fixation is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar or facet wiring techniques;
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
- Spinal degenerative surgery, as an adjunct to spinal fusions.
- The RESPONSE BandLoc Spinal Fixation may also be used in conjunction with other medical implants made of titanium alloy or CoCr alloy whenever "wiring" may help secure the attachment of other implants.
Product codes
OWI
Device Description
The Response BandLoc Spinal Fixation consists of a woven band, band clip, metal insert, tulip head and set screw. The metal insert, band, band clip and tulip head are assembled at the manufacturer and provided as a one piece assembly to the user. This tulip head/band assembly and the set screw are packaged in the same box but in separate peal packs. The tulip head assembly mates with a spine system rod and the set screw is tightened in the tulip head assembly securing it to the rod. Combinations of 5.5 and 6.0 diameter rods offered in titanium alloy, and/or cobalt chromium can be utilized. All implants are made from implantable grade materials and provided sterile and are single use only; the implants should not be re-used or re-sterilized under any circumstances. No accessories are offered with the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal
Indicated Patient Age Range
patients 8 years of age and older
Intended User / Care Setting
orthopedic surgery
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
Mechanical Testing:
- Study Type: Design verification testing
- Tests completed: Axial Grip, Axial Torsion, Static Tension, Construct Compression Fatigue
- Standard: ASTM F1717 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, and ASTM F1798 – "Standard Guide to Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants.
- Key results: The subject devices met the pre-determined acceptance criteria for all tests.
Biocompatibility:
- Test: Bacterial endotoxin test (BET) / Limulus amebocyte lysate (LAL) test
- Standard: ANSI/AAMI ST72:2011, ISO-10993, "Biological Evaluation of Medical Devices" Parts 1, 3, 5, 6, 10, 11, and 12, FDA Guidance #G95-1 (Flow Chart for the Selection of Toxicity Tests for 510(K)s)
- Key results: implants meet established endotoxin limits. Biocompatibility met.
Key Metrics
Not Found
Predicate Device(s)
K110348 – Zimmer Universal Clamp Spinal Fixation, K060009 – Abbott (Zimmer) Spine Universal Clamp
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 11, 2016
OrthoPediatrics Corp. Mr. Mark Fox Vice President. Regulatory Affairs 2850 Frontier Drive Warsaw, Indiana 46538
Re: K161267
Trade/Device Name: Response BandLoc Spinal Fixation Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: July 19, 2016 Received: July 20, 2016
Dear Mr. Fox:
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 (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) 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/ResourcesforYou/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,
VincentJ. Devlin -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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510(K) Number (if known): K161267
Device Name: Response BandLoc Spinal Fixation
Indications for Use:
The RESPONSE BandLoc Spinal Fixation is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
- · Spinal trauma surgery, used in sublaminar or facet wiring techniques;
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
- Spinal degenerative surgery, as an adjunct to spinal fusions.
- The RESPONSE BandLoc Spinal Fixation may also be used in conjunction with other medical implants made of titanium alloy or CoCr alloy whenever "wiring" may help secure the attachment of other implants.
团 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
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OrthoPediatrics Corp. Response BandLoc Spinal Fixation
510(K) Summary
| I. | Submitter | OrthoPediatrics Corp.
2850 Frontier Drive
Warsaw, IN 46538
(574) 268-6379 |
|------|---------------------|------------------------------------------------------------------------------------|
| | Contact | Mark Fox
Vice President, Regulatory Affairs |
| | Date Prepared | August 3, 2016 |
| II. | Device | |
| | Name of Device | Response BandLoc Spinal Fixation |
| | Classification Name | Bone Fixation, Cerclage |
| | Classification | Class II; 21 CFR 888.3010 |
| | Product Codes | OWI |
| III. | Predicates | K110348 – Zimmer Universal Clamp Spinal Fixation
(PRIMARY) |
| | | K060009 – Abbott (Zimmer) Spine Universal Clamp |
IV. Product Description
The Response BandLoc Spinal Fixation consists of a woven band, band clip, metal insert, tulip head and set screw. The metal insert, band, band clip and tulip head are assembled at the manufacturer and provided as a one piece assembly to the user. This tulip head/band assembly and the set screw are packaged in the same box but in separate peal packs. The tulip head assembly mates with a spine system rod and the set screw is tightened in the tulip head assembly securing it to the rod. Combinations of 5.5 and 6.0 diameter rods offered in titanium alloy, and/or cobalt chromium can be utilized.
4
All implants are made from implantable grade materials and provided sterile and are single use only; the implants should not be re-used or re-sterilized under any circumstances.
No accessories are offered with the system.
V. Indications For Use
The RESPONSE BandLoc Spinal Fixation is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar or facet wiring techniques;
- Spinal reconstructive surgery, incorporated into constructs for the purpose ● of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
- Spinal degenerative surgery, as an adjunct to spinal fusions.
- The RESPONSE BandLoc Spinal Fixation may also be used in conjunction with ● other medical implants made of titanium alloy or CoCr alloy whenever "wiring" may help secure the attachment of other implants.
VI. Comparison of Technological Characteristics
The fundamental scientific principles and technological characteristics, including the intended use, material, general design, and sizes of the device are the same as, or similar to, the predicate devices.
The subject and predicate devices are based on the following same technological elements:
- Implanted into the patient
- . Used with rods and other instrumentation to build a construct
- Identical materials
- Intended to provide temporary stabilization as a bone anchor during the ● development of solid bony fusion and aid in the repair of bone fractures
VII. Performance Data
The following performance data are provided in support of the substantial equivalence determination.
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Mechanical Testing
In accordance with, Guidance for Industry and FDA Staff - Spinal System 510(k)'s, OrthoPediatrics Corp. has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices.
Design verification testing was completed in accordance with ASTM F1717 -Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, and ASTM F1798 – "Standard Guide to Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. The tests completed were:
-
- Axial Grip
-
- Axial Torsion
-
- Static Tension
- · Construct Compression Fatigue
The subject devices met the pre-determined acceptance criteria for all tests.
Biocompatibility
The RESPONSE BandLoc Spinal Fixation implants are comprised of medical grade metals (i.e. Titanium Alloy (Ti-6A1-4V-ELI) per ASTM F136, and Polyethylene terephtalate thread (PET) and have the same type of body contact as other permanently implantable, (>30 days) contact duration, commercially available spinal system components.
RESPONSE BandLoc Spinal Fixation implants have been tested via bacterial endotoxin test (BET) also known as the Limulus amebocyte Iysate (LAL) test, and meet established endotoxin limits per ANSI/AAMI ST72:2011.
RESPONSE BandLoc Spinal Fixation instruments are comprised of the same material (medical grade stainless Steel) as other commercially available instruments and have patient contact for a transient duration (limited (