(148 days)
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "adjunct to fusion" for various spinal conditions, indicating its use in treating medical conditions.
No
This device is a surgical implant system designed for spinal stabilization and fusion, not for diagnosing conditions. It is used as an "adjunct to fusion" for various spinal indications.
No
The device description explicitly states that the system consists of physical components like rods, anchors (screws and hooks), interconnections, and fasteners, which are hardware implants.
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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant system (screws, rods, hooks, etc.) intended for the mechanical stabilization of the spine during fusion procedures. It is a physical device implanted into the body, not a test performed on a sample outside the body.
The information provided aligns with a Class II or Class III medical device used in surgery, not an IVD.
N/A
Intended Use / Indications for Use
The Inertia® Pedicle Screw and Deformity Correxxion™ System is intended for pedicle and non-pedicle immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Inertia® Pedicle Screw and Deformity Correxxion™ System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Inertia® Pedicle Screw and Deformity Correxxion™ System is to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes
NKB, KWP, MNI, MNH, OSH
Device Description
The Inertia® Pedicle Screw and Deformity Correxxion™ System consists of longitudinal members (rods), anchors (screws and hooks), interconnections (offset, rod-rod and crosslink) and fasteners in a variety of sizes to accommodate differing anatomic requirements.
The Inertia® Pedicle Screw and Deformity Correxxion™ System implants are sold sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior non-cervical spine (T1-S2/Ilium)
Indicated Patient Age Range
skeletally mature patients, pediatric patients (adolescent idiopathic scoliosis)
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)
Mechanical testing of worst case Inertia® Pedicle Screw and Deformity Correxxion™ System constructs included static and dynamic compression bending and static torsion according to ASTM F1717.
The mechanical test results demonstrate that Inertia® Pedicle Screw and Deformity Correxxion™ System performance is substantially equivalent to the predicate devices.
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.
CD Horizon® Spinal System (Medtronic Sofamor Danek – K152457), Tiger® Spine System (Corelink, LLC – K133369), Inertia® Pedicle Screw System (Nexxt Spine - K141376)
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.
Moss Miami™ Spinal System (DePuy AcroMed, Inc. - K022623), Synergy VLS Open (Interpore Cross International – K011437), Inertia® Pedicle Screw System (Nexxt Spine - K101278)
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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Image /page/0/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 a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, and they are connected by a flowing line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2016
Nexxt Snine LLC % Ms. Karen Warden President Backroads Consulting P.O. Box 566 Chesterland, Ohio 44026-2141
Re: K153453
Trade/Device Name: Inertia® Pedicle Screw and Deformity Correxxion™ System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class III Product Code: NKB, KWP, MNI, MNH, OSH Dated: March 25, 2016 Received: March 28, 2016
Dear Ms. Warden:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the
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Page 2 - Ms. Karen Warden
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.
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Inertia® Pedicle Screw and Deformity Correxxion™ System
Indications for Use (Describe)
The Inertia® Pedicle Screw and Deformity System is intended for pedicle and non-pedicle immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, cyphosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pediatic patients, the Inertia® Pedicle Screw and Deformity Correxxion™ System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The Inettia® Pedicle Screw and Deformity Correxxion™ System is to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)
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)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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510(k) Summary
| Date: | 30 November 2015 |
|---|---|
| Sponsor: | Nexxt Spine |
| 14425 Bergen Blvd, Suite B | |
| Noblesville, IN 46060 | |
| Office: 317.436.7801 | |
| Fax: 317.245.2518 | |
| Sponsor Contact: | Andy Elsbury, President |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Proposed Trade Name: | The Inertia® Pedicle Screw and Deformity Correxxion™ System |
| Common Name: | Posterior pedicle screw & hook system |
| Device Classification: | Class III |
| Classification Name: | Pedicle screw spinal system, Spinal interlaminal fixation orthosis |
| Regulations: | 888.3070, 888.3050 |
| Device Product Codes: | NKB, KWP, MNI, MNH, OSH |
| Device Description: | The Inertia® Pedicle Screw and Deformity Correxxion™ System consists of |
| longitudinal members (rods), anchors (screws and hooks), interconnections | |
| (offset, rod-rod and crosslink) and fasteners in a variety of sizes to | |
| accommodate differing anatomic requirements. | |
| The Inertia® Pedicle Screw and Deformity Correxxion™ System implants | |
| are sold sterile and non-sterile. | |
| Indications for Use: | The Inertia® Pedicle Screw and Deformity Correxxion™ System is intended |
| for pedicle and non-pedicle immobilization and stabilization of the posterior | |
| non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct | |
| to fusion for the following indications: degenerative disc disease (defined as | |
| back pain of discogenic origin with degeneration of the disc confirmed by | |
| history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or | |
| dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or | |
| lordosis), tumor, pseudarthrosis, and/or failed previous fusion. | |
| When used for posterior non-cervical pedicle screw fixation in pediatric | |
| patients, the Inertia® Pedicle Screw and Deformity Correxxion™ System | |
| implants are indicated as an adjunct to fusion to treat adolescent idiopathic | |
| scoliosis. The Inertia® Pedicle Screw and Deformity Correxxion™ System is | |
| to be used with autograft and/or allograft. Pediatric pedicle screw fixation is | |
| limited to a posterior approach. | |
| Materials: | Inertia® Pedicle Screw and Deformity Correxxion™ System from Ti-6Al-4V |
| ELI titanium alloy (ASTM F136) and Cobalt Chrome (per ASTM F1537. | |
| Predicate Devices: | Primary: CD Horizon® Spinal System (Medtronic Sofamor Danek – |
| K152457) | |
| Additional: Tiger® Spine System (Corelink, LLC – K133369) and Inertia® | |
| Pedicle Screw System (Nexxt Spine - K141376) | |
| Reference Devices: | Moss Miami™ Spinal System (DePuy AcroMed, Inc. - K022623), Synergy |
| VLS Open (Interpore Cross International – K011437) and Inertia® Pedicle | |
| Screw System (Nexxt Spine - K101278) |
5
| Performance Data: | Mechanical testing of worst case Inertia® Pedicle Screw and Deformity
Correxxion™ System constructs included static and dynamic compression
bending and static torsion according to ASTM F1717.
The mechanical test results demonstrate that Inertia® Pedicle Screw and
Deformity Correxxion™ System performance is substantially equivalent to
the predicate devices. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics: | The Inertia® Pedicle Screw and Deformity Correxxion™ System possesses
the same technological characteristics as one or more of the predicate
devices. These include:
• intended use (as described above)
• basic design (rod and screw configuration),
• material (titanium alloy),
• sizes (dimensions are comparable to those offered by the predicate
systems) and |
| | The fundamental scientific technology of the Inertia® Pedicle Screw and
Deformity Correxxion™ System is the same as previously cleared devices. |
| Conclusion: | The Inertia® Pedicle Screw and Deformity Correxxion™ System possesses
the same intended use and technological characteristics as the predicate
devices. Therefore Inertia® Pedicle Screw and Deformity Correxxion™
System is substantially equivalent for its intended use. |