(379 days)
Not Found
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "Spinal System" intended for "correction, stabilization, adjustment, and fixation of the scoliotic spine," which directly treats a medical condition.
No
Explanation: The device is a pedicle screw system used for correction, stabilization, adjustment, and fixation of the scoliotic spine. It does not perform any diagnostic function.
No
The device description explicitly lists physical components such as rods, pedicle screws, fixed connectors, and a cross connector, indicating it is a hardware-based medical device.
No, the Orthobiom™ Spinal System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Orthobiom™ Spinal System Function: The Orthobiom™ Spinal System is a surgical implant used within the body to correct and stabilize the spine. It is a mechanical device, not a diagnostic test.
The provided information clearly describes a surgical implant system for treating scoliosis, not a device for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Orthobiom™ Spinal System is a posterior, non-cervical pedicle screw system indicated to treat pediatric scoliosis by (1) correction, (2) stabilization, (3) adjustment and (4) fixation of the scoliotic spine.
The Orthobiom™ Spinal System is intended to be used with bone graft.
Product codes
MNI, 87MNI
Device Description
The Orthobiom™ Spinal System is designed as a pedicle screw based system. The system consists of rods, pedicle screws, fixed connectors, and one cross connector. The Orthobiom™ Spinal System uses rods, screws, and/or hooks to achieve correction and subsequent maintenance of the corrected scoliotic spine and use fusion to maintain the corrected spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, non-cervical
Indicated Patient Age Range
pediatric
Intended User / Care Setting
Prescription Use
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)
Testing performed indicate that the Orthobiom™ Spinal System is as mechanically sound as predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K781443, K994121, K974757, K962984, K012916
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K071663
Page lot 1
510(k) Summary according to 807.92(c)
JUL - 2 2008
| Contact: | Justin Eggleton
Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H Street NW, 12th Floor
Washington, DC 20005
(202) 552 - 5800 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Orthobiom™ Spinal System |
| Common Name: | Pedicle Screw System |
| Device Regulatory Class: | Pedicle Screw System (21 CFR 888.3070)
Class II |
| Product Code: | 87MNI |
Indications For Use:
The Orthobiom™ Spinal System is a posterior, non-cervical pedicle screw system indicated to treat pediatric scoliosis by (1) correction, (2) stabilization, (3) adjustment and (4) fixation of the scoliotic spine.
The Orthobiom™ Spinal System is intended to be used with bone graft.
Device Description:
The Orthobiom™ Spinal System is designed as a pedicle screw based system. The system consists of rods, pedicle screws, fixed connectors, and one cross connector. The Orthobiom™ Spinal System uses rods, screws, and/or hooks to achieve correction and subsequent maintenance of the corrected scoliotic spine and use fusion to maintain the corrected spine.
Predicate Device(s):
The Orthobiom Spinal System™ was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. These predicates include Harrington Rods (K781443), Synthes Small Stature USS (K994121), DePuy Spine Kaneda Spinal System (K974757), Acromed Pediatric ISOLA (K962984), and DePuy Spine Frontier Anterior Deformity System (K012916).
Performance Standards:
Testing performed indicate that the Orthobiom™ Spinal System is as mechanically sound as predicate devices.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Musculoskeletal Clinical Regulatory Adviser, LLC % Mr. Justin Eggleton 1131 H Street NW 12th Floor Washington, DC 20005
JUL - 2 2008
Re: K071668 Trade/Device Name: Orthobiom™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI Dated: April 2, 2008 Received: April 3, 2008
Dear Mr. Eggleton:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
2
Page 2 - Mr. Justin Eggleton
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K071668
Device Name: Orthobiom™ Spinal System
Indications for Use:
The Orthobiom™ Spinal System is a posterior, non-cervical pedicle screw system indicated to treat pediatric scoliosis by (1) correction, (2) stabilization, (3) adjustment and (4) fixation of the scoliotic spine.
The Orthobiom™ Spinal System is intended to be used with bone graft.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
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)
510(k) Number
R
(Division Sign-Off) Division of General, Restorative, and Neurological Devices