(154 days)
Not Found
No
The provided text describes a mechanical spinal implant system and its components. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is described as an "adjunct to fusion" intended to "provide immobilization of spinal segments," and the indications for use are medical conditions such as degenerative disc disease, trauma, and spinal deformities. These functions and indications align with the definition of a therapeutic device designed to treat or alleviate health conditions.
No
The device is described as a pedicle screw system ("Ibis® Pedicle Screw System") intended to provide "immobilization of spinal segments... as an adjunct to fusion." This function is therapeutic (stabilizing the spine), not diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly lists physical components made of Titanium Alloy (Ti6Al4V), such as rods, screws, and set screws, which are hardware.
No, 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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Ibis® Pedicle Screw System is a surgical implant intended to provide structural support and immobilization to the spine during fusion. It is a physical device implanted in the body, not a device used to analyze samples outside the body.
- Lack of IVD Characteristics: The provided information does not mention any analysis of biological samples, laboratory testing, or diagnostic purposes. The device's function is purely mechanical and structural.
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, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1 - Sacrum/Ileum) 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
Device Description
The Ibis® Pedicle Screw System consists of bulleted rods; cannulated polyaxial, monoaxial, extended length (Ibis® XL) 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
posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1 - Sacrum/Ileum)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following mechanical tests were conducted:
- Static Compression Bending in accordance with ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model"
- . Dynamic Compression Bending in accordance with ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model"
- . Axial Torque Gripping Capacity in accordance with ASTM F1798 "Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants"
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.
Ibis® Pedicle Screw System (K142146), Pagoda® Pedicle Screw System (K131785), EXPEDIUM® and VIPER® Systems (K101993)
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).
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§ 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
March 30, 2017
Ortho Development Corporation Ms. Lindsay Martin Manager, Regulatory Affairs 12187 South Business Park Drive Draper, Utah 84020
Re: K162995
Trade/Device Name: Ibis® Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: January 10, 2017 Received: January 11, 2017
Dear Ms. Martin:
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,
Mark N. Melkerson -S
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) K162995
Device Name Ibis® Pedicle Screw System
Indications for Use (Describe)
The Ibis® Pedicle Screw System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1 - Sacrum/Ileum) 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)
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510(k) Summary
| Name of Sponsor: | Ortho Development Corporation
12187 South Business Park Drive
Draper, Utah 84020 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Lindsay Martin
Manager, Regulatory Affairs
Telephone: (801) 553-9991
Facsimile: (801) 553-9993
Email: LMartin@orthodevelopment.com |
| Date Prepared: | March 27, 2017 |
| Proprietary Name: | Ibis® Pedicle Screw System |
| Common Name: | Thoracolumbosacral Pedicle Screw System |
| Classification: | 21 CFR 888.3070 |
| Device Product Code: | NKB |
| Class: | Class II |
| Primary Predicate Device: | Ibis® Pedicle Screw System (K142146)
Ortho Development Corporation |
| Additional Predicate Devices: | Pagoda® Pedicle Screw System (K131785)
Ortho Development Corporation
Additions to the EXPEDIUM® and VIPER® Systems (K101993)
Depuy Spine, Inc |
Description
The Ibis® Pedicle Screw System consists of bulleted rods; cannulated polyaxial, monoaxial, extended length (Ibis® XL) 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).
4
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 or allograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1 – Sacrum/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
Basis for Substantial Equivalence:
The Ibis® XL Cannulated Polyaxial Screws are a line extension of the Ibis® Pedicle Screw System and have the following similarities to those which previously received 510(k) concurrence (K142146):
- have the same indicated use,
- . incorporate the same basic polyaxial ball-socket and screw thread design,
- . incorporate the same materials,
- have the same interconnection components (set screw and 5.5mm bulleted rod),
- have the same shelf life, and
- . are packaged and sterilized using the same materials and processes.
In summary, the Ibis® XL Cannulated Polyaxial Screws described in this submission are, in our opinion, substantially equivalent to the predicate device.
Nonclinical Test Summary:
The following mechanical tests were conducted:
- Static Compression Bending in accordance with ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model"
- . Dynamic Compression Bending in accordance with ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model"
- . Axial Torque Gripping Capacity in accordance with ASTM F1798 "Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants"
Conclusions:
Ibis® XL Cannulated Polyaxial Screw has substantially the same intended use, indications for use, materials, general dimensions, performance, and principles of operation as the predicate devices.