(90 days)
Not Found
Not Found
No
The summary describes a mechanical spinal fixation system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The UCR Spinal System is indicated for correcting spinal disorders and providing stabilization of the spine to permit spinal fusions, treating severe spondylolisthesis, and immobilizing/stabilizing spinal segments as an adjunct to fusion for various spinal instabilities or deformities. These uses clearly fall under the definition of a therapeutic device designed to treat a medical condition.
No
Explanation: The device is a spinal implant system used for stabilization and fusion, not for diagnosing medical conditions.
No
The device description explicitly details physical components made of titanium alloy and stainless steel, which are hardware.
Based on the provided text, this device 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, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the UCR Spinal System hooks and components are implants designed for surgical placement within the spine to correct spinal disorders and provide stabilization.
- Intended Use: The intended use is focused on surgical intervention and stabilization of the spine, not on analyzing biological samples.
The device is a surgical implant and associated instruments, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The intended use of the UCR Spinal System hooks and their components is substantially equivalent to the intended use of the predicate devices. The intended use of the UCR Spinal System and hooks is as a temporary or permanent posterior implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The intended use and indications when used as a Spondylolisthesis Spinal Fixation Device System are:
- The UCR Spinal System is a pedicle screw system indicated for the treatment ● of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The intended use and indications when used as a Pedicle Screw Spinal System are:
- The UCR Spinal System is a pedicle screw system 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:
- degenerative spondylolisthesis with objective evidence of neurological ● impairment,
- fracture, ●
- dislocation,
- scoliosis,
- kyphosis,
- spinal tumor, and
- failed previous fusion (pseudoarthrosis). ●
Hook Spinal System indications are limited to T1-L5 and are:
- degenerative disc disease (as defined by back pain of discogenic origin with ● degeneration of the disc confirmed by patient history ad radiographic),
- . spinal stenosis.
- . spondylolisthesis,
- . spinal deformities (scoliosis, kyphosis, and/or lordosis),
- fracture,
- pseudarthosis, ●
- tumor resection, and/or ●
- failed previous fusion. .
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH, KWP
Device Description
The UCR Spinal System hooks include titanium alloy laminar and pedicle hook assemblies. The laminar hooks will be available in widths of 5.5mm and 7.0mm and in five heights that range from 5.0 to 10.0mm. The pedicle spinal hooks will be available in widths of 7.5mm and 9.0mm and in four heights that range from 5.0 to 9.5mm. The laminar hooks will also be available in offset versions. The hook assembly is comprised of a hook body, temporary fixation pin, cap, and set screw. The hook assembly is designed to be compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.
The UCR Spinal System hooks also utilize a variety of instruments to assist in placement of the devices. These instruments include a hook holder, hook inserter, temporary fixation pin inserter, power rod gripper, and a rocker. The instruments will be fabricated from stainless steel and Radal. The product is supplied "NON-STERILE" and must be sterilized prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L5-S1 vertebra (when used as Spondylolisthesis Spinal Fixation Device System), thoracic, lumbar, and sacral spine (when used as Pedicle Screw Spinal System), T1-L5 (when used as Hook Spinal System).
Indicated Patient Age Range
Skeletally mature 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)
Not Found
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.
Not Found
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
UCR Spinal System
Image /page/0/Picture/1 description: The image shows the text "K031381 p 1/3" at the top and the word "CONFIDENTIAL" at the bottom. The text appears to be handwritten or printed in a bold, somewhat irregular font. The word "CONFIDENTIAL" is in a smaller font size than the alphanumeric string above it.
510(K) SUMMARY
Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR & 807.92.
| Submitter Information: | SeaSpine, Inc.
Contact: Kirt Stephenson
6276 River Crest Drive, Suite E
Riverside, CA 92507-0754
Phone: 909-656-4850 Fax: 909-656-5530 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Registration Number: | 2032593 |
| Submission Correspondent: | The Regulatory Affairs Company
Contact: Diana Smith
727 Park Boulevard
San Diego, CA 92101
Phone: 619-251-9132 Fax: 619-696-9883 |
| Date Summary Prepared: | April 7, 2003 |
| Classification Name: | Spondylolisthesis Spinal Fixation Device
System (Class II) – MNH 888-3070
Pedicle Screw Spinal System (Class II) –
MNI 888-3070
Spinal Interlaminal Fracture Orthosis (Class
II) - KWP 88-3050 |
| Common/Usual Name: | Laminar and Pedicle Hook Assemblies and
Instruments |
| Device Trade Name: | UCR Spinal System |
The primary devices used for comparison in this summary are Cross Medical Products' Synergy™ Posterior Spinal System and Medtronic Sofamor Danek's CD Horizon™.
- Intended Use: (The statements of intended use are identical.)
The intended use of the UCR Spinal System hooks and their components is substantially equivalent to the intended use of the predicate devices. The intended use of the UCR Spinal System and hooks is as a temporary or permanent posterior implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The intended use and indications when used as a Spondylolisthesis Spinal Fixation Device System are:
1
UCR Spinal System
- The UCR Spinal System is a pedicle screw system indicated for the treatment ● of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
CONFIDENTIAL
The intended use and indications when used as a Pedicle Screw Spinal System are:
- The UCR Spinal System is a pedicle screw system 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:
- degenerative spondylolisthesis with objective evidence of neurological ● impairment,
- fracture, ●
- dislocation,
- scoliosis,
- kyphosis,
- spinal tumor, and
- failed previous fusion (pseudoarthrosis). ●
Hook Spinal System indications are limited to T1-L5 and are:
- degenerative disc disease (as defined by back pain of discogenic origin with ● degeneration of the disc confirmed by patient history ad radiographic),
- . spinal stenosis.
- . spondylolisthesis,
- . spinal deformities (scoliosis, kyphosis, and/or lordosis),
- fracture,
- pseudarthosis, ●
- tumor resection, and/or ●
- failed previous fusion. .
2. Description:
The UCR Spinal System hooks include titanium alloy laminar and pedicle hook assemblies. The laminar hooks will be available in widths of 5.5mm and 7.0mm and in five heights that range from 5.0 to 10.0mm. The pedicle spinal hooks will be available in widths of 7.5mm and 9.0mm and in four heights that range from 5.0 to 9.5mm. The laminar hooks will also be available in offset versions. The hook assembly is comprised of a hook body, temporary fixation pin, cap, and set screw. The hook assembly is designed to be compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use
The UCR Spinal System hooks also utilize a variety of instruments to assist in placement of the devices. These instruments include a hook holder, hook inserter,
2
Image /page/2/Picture/0 description: The image contains the text "K031381" on the top line and the word "CONFIDENTIAL" on the second line. The text is black and the background is white. The text is slightly blurry.
UCR Spinal System
temporary fixation pin inserter, power rod gripper, and a rocker. The instruments will be fabricated from stainless steel and Radal. The product is supplied "NON-STERILE" and must be sterilized prior to use.
3. Technological Characteristics:
The hook assembly has been designed as an addition to the current UCR Spinal System. The hook system is new to the UCR Spinal System line, but has substantially equivalent technological characteristics to the predicate devices. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, and material.
4. Comparison Analysis:
The overall design of the UCR Spinal System hooks and their components are substantially equivalent to the predicate devices. See Table 1 on the following page for a comparison of the UCR Spinal System hooks and the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2003
SeaSpine, Inc. c/o Ms. Diana Smith Principal The Regulatory Affairs Company 727 Park Boulevard San Diego, California 92101
Re: K031381 Trade/Device Name: UCR Spinal System Regulatory Number: 21 CFR 888.3070 (b)(1), 888.3050 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNI, MNH, KWP Dated: April 16, 2003 Received: May 1, 2003
Dear Ms. Smith:
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
4
Page 2 - Richard W. Treharne, Ph.D.
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. 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
CONFIDENTIAL
UCR Spinal System
Indications for Use Statement
16031381
510(k) Number (if known):
Device Name: UCR Spinal System
The intended use of the UCR Spinal System hooks and their components is substantially equivalent to the intended use of the predicate devices. The intended use of the UCR Spinal System and hooks is as a temporary or permanent posterior implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The intended use and indications when used as a Spondylolisthesis Spinal Fixation Device System are:
-
The UCR Spinal System is a pedicle screw system indicated for the treatment . of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The intended use and indications when used as a Pedicle Screw Spinal System are: -
The UCR Spinal System is a pedicle screw system 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:
-
degenerative spondylolisthesis with objective evidence of neurological ● impairment,
-
fracture, ●
-
dislocation, ●
-
scoliosis,
-
. kyphosis,
-
spinal tumor, and
-
failed previous fusion (pseudoarthrosis). ●
Mark N. Milburn
(Division Sign-Off)
Division of Gene al. Restorative and Neurological Devices
510(k) Number__K03/38/
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR § 801.109) OR
Over-The-Counter-Use
6
CONFIDENTIAL
UCR Spinal System
Indications for Use Statement continued
Hook Spinal System indications are limited to T1-L5 and are:
- degenerative disc disease (as defined by back pain of discogenic origin with ● degeneration of the disc confirmed by patient history ad radiographic),
- . spinal stenosis,
- spondylolisthesis, .
- spinal deformities (scoliosis, kyphosis, and/or lordosis), .
- . fracture,
- pseudarthosis,
- . tumor resection, and/or
- failed previous fusion. .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR § 801.109) OR
Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________
21