(57 days)
Not Found
No
The document describes a mechanical spine fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The Response Spine System is intended for posterior, non-cervical fixation in pediatric patients to treat adolescent idiopathic scoliosis, which is a therapeutic intervention.
No
The device description and intended use indicate it is an implantable system for spinal fixation, not a device used to diagnose medical conditions.
No
The device description explicitly lists hardware components such as rods, anchors (hooks and screws), interconnection components, and fasteners.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Response Spine System is a surgical implant used for spinal fixation. It consists of rods, screws, hooks, and connectors.
- Intended Use: The intended use is for posterior, non-cervical fixation in pediatric patients with adolescent idiopathic scoliosis, as an adjunct to fusion. This is a surgical procedure, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant used for structural support and stabilization within the body, not a device used to analyze biological samples outside the body.
N/A
Intended Use / Indications for Use
The Response Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/ilium and hook fixation (T1-L5)) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.
Product codes (comma separated list FDA assigned to the subject device)
OSH; KWP
Device Description
The Response Spine System consists of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of sizes, including fixed angled screws, to accommodate differing anatomic requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical fixation (pedicle screw fixation T1-S2/ilium and hook fixation (T1-L5))
Indicated Patient Age Range
pediatric patients
Intended User / Care Setting
Not Found
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)
Static and dynamic compression bending tests and static torsion tests, performed according to ASTM F1717, demonstrated the device to be substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
OrthoPediatrics' OP Spine System (K120291 and K121250), Medtronic CD Horizon (K091445)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
510(k) -- Section 1: OrthoPediatrics Response Spine System
K130655 Page 1 of 2
MAY 0 8 2013
| NAME OF FIRM: | OrthoPediatrics, Corp.
2850 Frontier Drive
Warsaw, IN 46582 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | March 7, 2013 |
| 510(K) CONTACT: | Mark Fox
Vice President, Regulatory Affairs
Tel: (574) 268-6379 |
| PROPOSED TRADE
NAME: | Response Spine System |
| DEVICE
CLASSIFICATION: | Class II; 21 CFR 888.3070 and 21 CFR 888.3050 |
| CLASSIFICATION
NAME: | Pedicle screw spinal system , adolescent idiopathic scoliosis
orthosis; spinal interlaminal fixation orthosis |
| PRODUCT CODE: | OSH; KWP |
| DEVICE
DESCRIPTION: | The Response Spine System consists of longitudinal
members (rods), anchors (hooks and screws),
interconnection components (rod-to-rod and anchor-to-rod
connectors) and fasteners in a variety of sizes, including fixed
angled screws, to accommodate differing
anatomic
requirements. |
| INDICATIONS FOR
USE: | The Response Spine System is intended for posterior, non-
cervical fixation (pedicle screw fixation T1-S2/ilium and hook
fixation (T1-L5)) in pediatric patients is indicated as an
adjunct to fusion to treat adolescent idiopathic scoliosis. The
device is intended to be used with autograft and/or allograft. |
| MATERIALS: | Medical grade titanium alloy - ASTM F136-08e1
Medical grade cobalt-chromium-molybdenum - ASTM
F1537-08 |
| PREDICATE DEVICES: | OrthoPediatrics' OP Spine System (K120291 and K121250)
Medtronic CD Horizon (K091445) |
| | |
| TECHNOLOGIC
CHARACTERISTICS: | The fundamental scientific principles and technological
characteristics, including the material, and general design,
and sizes of the device are substantially the same as the
predicate devices. Fixed angle (non-swivel) screws have
been added to the system while the smaller diameter
longitudinal rod has been eliminated from the system. |
| PERFORMANCE
DATA: | Static and dynamic compression bending tests and static
torsion tests, performed according to ASTM F1717,
demonstrated the device to be substantially equivalent to the
predicate devices. |
| CONCLUSION: | The Response Spine System has the same intended use and
technological characteristics as the predicate devices.
Therefore the Response Spine System is substantially
equivalent for its intended use. |
510(k) Summary
·
.
1
י
: .
.
.
'
.
、
.
:
:
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2013
OrthoPediatrics, Corporation % Mr. Mark Fox Vice President, Regulatory Affairs 2850 Frontier Drive Warsaw, Indiana 46582
Re: K130655
Trade/Device Name: Response Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: OSH, KWP Dated: March 20, 2013 Received: March 21, 2013
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Mark Fox
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
ring theith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K130655
Device Name: OrthoPediatrics' Response Spine System
Indications for Use:
The Response Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/ilium and hook fixation (T1-L5)) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.
Prescription Use ___________ X or 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 (ODE)
Ronald P. Jean -S
(Division Sign-Off)
Division of Orthopedic Devices
510(k) Number: K130655