(375 days)
Not Found
No
The 510(k) summary describes a mechanical spinal pedicle screw system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the treatment of severe spondylolisthesis, instabilities, and deformities of the spine as an adjunct to fusion, which are conditions that require therapeutic intervention.
No
The device description clearly states its purpose as a "posterior spinal fixation system" designed to "stabilize and promote spinal fusion." Its intended uses, such as treating spondylolisthesis, fractures, or scoliosis, involve providing structural support and immobilization rather than detecting or identifying diseases.
No
The device description explicitly states it is a "posterior spinal fixation system which consists of pedicle screws (monoaxial screw & poly-axial screw), rod and locking cap," all of which are physical hardware components.
Based on the provided information, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the ULC spinal pedicle screw system is a posterior spinal fixation system consisting of screws, rods, and locking caps. Its intended use is for surgical implantation to stabilize and promote spinal fusion in patients with various spinal conditions.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is purely mechanical and structural within the body.
Therefore, the ULC spinal pedicle screw system falls under the category of a surgical implant or medical device used for structural support and stabilization, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ULC spinal pedicle screw systems are intended for posterior and noncervical pedicle fixation for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion 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.
In addition, the ULC is 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 (pseudarthrosis).
Product codes
MNI, MNH
Device Description
The ULC spinal pedicle screw system is one touch single unitary locking cap, posterior spinal fixation system which consists of pedicle screws (monoaxial screw & poly-axial screw), rod and locking cap.
The ULC system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Components of the ULC system are supplied non-sterile and single use.
The ULC system is fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical grade stainless steel are available for the application and removal of the ULC Spinal pedicle screw systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L5-S1 vertebra, lumbar and sacral spine (L3 to sacrum), thoracic, lumbar and sacral spine
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)
Bench testing as listed in Section 14 and Appendix D. was conducted in accordance with ASTM F1717. It demonstrates substantial equivalence to the above listed predicate devices in terms of materials, design, indications for use and operational principles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072436, K071857, K053115, K051971
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.
0
ICOF 3077
Premarket Notification 510(k) 5. 510(k) Summary
5. 510(k) Summary
[As Required by 21 CFR 807.87(h) & 21 CFR 807.92]
OCT 2 6 2009
1. Submission information
| Name of Company: OTIS Biotech Co., Ltd |
|---|
| FDA registration No. 3005140381 |
| #514 Sihwa industrial complex 2Ba Block |
| Jeongwang-Dong, Siheung-si |
| Gyounggi-Do, Republic of Korea 429-450 |
| Tel: 82-31-319-0406 |
| Fax: 82-31-319-0414 |
| Contact: | JiSuk Yoo |
|---|---|
| Researcher | |
| E-mail: jsy1979@otisbiotech.com | |
| Tel: 82-31-414-4616 | |
| Fax: 82-31-411-1076 |
30 Sep, 2008 Date Prepared:
2. Device Identification
| Trade Name: | ULC spinal pedicle screw system |
|---|---|
| Common Name: | Pedicle Screw Spinal Fixation system |
| Classification: | Class II |
| MNI 888.3070 - Orthosis, Spinal Pedicle Fixation. | |
| MNH 888.3070 - Orthosis, Spondyloisthesis Spinal Fixation. |
3. Substantial Equivalence Predicate Legally Marketed Devices
BK Meditech Co., Ltd., MEGA spine system -- MNI MNH - K072436 Jemo Spine, LLC., DELTA™ spinal fusion system - MNI MNH KWQ -K071857
Stryker Spine, Xia 9 Spinal system - MNI MNH KWP KWQ - K053115
1
U&I Corporation, OPTIMATM Spinal System - MNI MNH KWQ - K051971
The substantial equivalence of this device is based on equivalence in intended use, materials, designs and operational principles to the above listed predicate devices.
4. Device Description
The ULC spinal pedicle screw system is one touch single unitary locking cap, posterior spinal fixation system which consists of pedicle screws (monoaxial screw & poly-axial screw), rod and locking cap.
The ULC system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Components of the ULC system are supplied non-sterile and single use.
The ULC system is fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical grade stainless steel are available for the application and removal of the ULC Spinal pedicle screw systems.
5. Indications for Use
The ULC spinal pedicle screw systems are intended for posterior and noncervical pedicte fixation for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion 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.
In addition, the ULC is 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 (pseudarthrosis).
5 - 2
ge 2 of 3
2
Premarket Notification 510(k) 5. 510(k) Summary
6. Statement of Technological Comparison
Bench testing as listed in Section 14 and Appendix D. was conducted in accordance with ASTM F1717. It demonstrates substantial equivalence to the above listed predicate devices in terms of materials, design, indications for use and operational principles.
5-3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Otis Biotech Co., LTD % Jisuk Yoo 514, 2-BA Block, Jungwang-Dong, Sihma Sihung City, Kyonggi-do Republic of Korea 429-450
OCT 2 $ 2009
Re: K083077
Trade/Device Name: ULC Spinal Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: MNI, MNH Dated: October 21, 2009 Received: October 21, 2009
Dear Mr. Yoo:
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 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 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.
4
Page 2 - Mr. Jisuk Yoo
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4. Indications for Use
510(k) Number: [co&3077 Device Name: ULC spinal pedicle screws system Indications For Use:
The ULC spinal pedicle screw systems are intended for posterior and noncervical pedicle fixation for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion 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.
In addition, the ULC is 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 (pseudarthrosis).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
| Artificial Joint Research Center | |
|---|---|
| OTIS Biotech co., Ltd. | (Division Sign-Off) |
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | K083027 |
4-1