(128 days)
Not Found
No
The device description and performance studies focus on the mechanical components and testing of a pedicle screw system, with no mention of AI or ML.
Yes
The device is intended to immobilize spinal segments as an adjunct to fusion for various medical conditions, indicating a therapeutic purpose to treat or alleviate a medical condition.
No
The device description states its purpose is to provide immobilization of spinal segments as an adjunct to fusion, and it consists of components like rods and screws for this mechanical function. It does not mention any diagnostic capabilities.
No
The device description explicitly lists physical components made of Titanium Alloy (Ti6Al4V), such as rods, screws, and set screws, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Ibis™ Pedicle Screw System is for "immobilization of spinal segments... as an adjunct to fusion." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details physical components like rods, screws, and set screws made of Titanium Alloy. These are physical devices for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis.
Therefore, the Ibis™ Pedicle Screw System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ibis™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, noncervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1 – S1/Ilium) for the following indications:
- Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
-
- Degenerative Spondylolisthesis with objective evidence of neurologic impairment
-
- Trauma (fracture or dislocation)
-
- Spinal tumor
-
- Failed previous fusion (pseudarthrosis)
-
- Spinal stenosis
-
- Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNI, MNH
Device Description
The Ibis™ Pedicle Screw System consists of bulleted rods; cannulated polyaxial, and extended tab screws; and set screws; which can be variously assembled to provide immobilization of the thoracolumbar and lumbosacral spine. The Ibis™ Pedicle Screw System maintains compatibility with the Pagoda™ Pedicle Screw System. All components are made from Titanium Alloy (Ti6Al4V).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral/iliac spine (T1 – S1/Ilium)
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)
- Static and dynamic compression testing per ASTM F1717
- Static torsion testing per ASTM F1717
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.
Pagoda™ Pedicle Screw System (K131785), Tiger Spine System (K113058), Pangea System (K052123)
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2014
Ortho Development Corporation Mr. Mike Ensign Director of Quality Assurance and Regulatory Affairs 12187 South Business Park Drive Draper, Utah 84020
Re: K142146
Trade/Device Name: Ibis™ Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: November 4, 2014 Received: November 5, 2014
Dear Mr. Ensign:
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 devicerelated 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.
1
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" (21 CFR 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 yours,
Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142146
Device Name Ibis™ Pedicle Screw System
Indications for Use (Describe)
The Ibis™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, noncervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (TI - S1/Illium) for the following indications:
- Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
-
- Degenerative Spondylolisthesis with objective evidence of neurologic impairment
-
- Trauma (fracture or dislocation)
-
- Spinal tumor
-
- Failed previous fusion (pseudarthrosis)
-
- Spinal stenosis
-
- Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis
Type of Use (Select one or both, as applicable)
2 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 A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Vincent J. Devlin -S 2014.12.11 08:18:02 -05'00
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3
12187 So. Business Park Drive
Draper, Utah 84020
801-553-9991/fax 553-9991/fax 553-9993
orthodevelopment.com
Image /page/3/Picture/3 description: The image shows the logo for Ortho Development. The logo consists of a purple circle with three gray arcs above it, followed by the word "ORTHO" in purple, and the word "DEVELOPMENT" in gray below it. The logo is simple and modern, and the colors are eye-catching.
Section 5 510(K) Summary
| NAME OF SPONSOR: | Ortho Development Corporation
12187 South Business Park Drive
Draper, Utah 84020 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Mike Ensign
Director of Quality Assurance and Regulatory Affairs
Telephone: (801) 553-9991
Facsimile: (801) 553-9993
Email: mensign@odev.com |
| DATE PREPARED: | December 10, 2014 |
| PROPRIETARY NAME: | Ibis™ Pedicle Screw System |
| COMMON NAME: | Pedicle Screw Spinal System |
| CLASSIFICATION: | 21 CFR 888.3070 Pedicle screw spinal system |
| DEVICE PRODUCT CODES: | NKB
MNH
MNI |
| CLASS: | III |
| PRIMARY PREDICATE DEVICE: | Pagoda™ Pedicle Screw System (K131785)
Ortho Development Corporation |
| ADDITIONAL PREDICATE DEVICES: | Tiger Spine System (K113058)
CoreLink, LLC
Pangea System (K052123)
Synthes Spine |
4
Description
The Ibis™ Pedicle Screw System consists of bulleted rods; cannulated polyaxial, and extended tab screws; and set screws; which can be variously assembled to provide immobilization of the thoracolumbar and lumbosacral spine. The Ibis™ Pedicle Screw System maintains compatibility with the Pagoda™ Pedicle Screw System. All components are made from Titanium Alloy (Ti6Al4V).
Indications
The Ibis™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, noncervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1 – S1/Ilium) for the following indications:
-
- Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
-
- Degenerative Spondylolisthesis with objective evidence of neurologic impairment
-
- Trauma (fracture or dislocation)
-
- Spinal tumor
-
- Failed previous fusion (pseudarthrosis)
-
- Spinal stenosis
-
- Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis
Summary of Technological Characteristics
The Ibis™ Pedicle Screw System components incorporate the same technological characteristics as the predicate devices to stabilize and immobilize the thoracolumbar and lumbosacral spine as an adjunct to fusion. At a high level, the subject and predicate devices are based on the following same technological elements:
- Components are manufactured from Titanium Alloy (Ti6Al4V)
- Polyaxial and monoaxial pedicle screws are used to attach to the vertebrae
- . Pedicle screws are cannulated to facilitate placement over a k-wire
- Same pedicle screw thread form
- Same locking mechanism used to rigidly fix the polyaxial pedicle screws to the rod
- . Extended tab pedicle screws are used to aid in rod reduction
- Use of instrumentation to aid in percutaneous placement of pedicle screws and rods
Summary of Non-Clinical Testing
- Static and dynamic compression testing per ASTM F1717
- Static torsion testing per ASTM F1717
Conclusions
Substantial equivalence of the Ibis™ Pedicle Screw System to previously cleared predicate devices has been demonstrated based upon on similarities in intended use, design, materials, manufacturing methods, packaging, and mechanical test results.