(34 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fusion system consisting of screws, rods, and caps. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are mechanical tests, not software validation.
Yes
The device is a spinal fusion system designed to provide immobilization and stabilization of spinal segments, treat severe Spondylolisthesis, and address various instabilities or deformities of the spine. These are all therapeutic actions aimed at treating medical conditions.
No
Explanation: The device is described as a "posterior spinal fixation device" and a "pedicle screw system" intended for treatment, immobilization, and stabilization of spinal segments. It is a surgical implant, not a device used to identify or diagnose a condition.
No
The device description explicitly states it consists of physical components like pedicle screws, rods, caps, and a transverse linking mechanism, all fabricated from titanium alloy. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, the Jemo Spine, LLC, DELTA™, Spinal Fusion System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used for spinal fixation and fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of the implant (screws, rods, etc.) and the materials used. It does not mention any components or processes related to testing samples from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The Jemo Spine system is a physical implant used to stabilize the spine.
N/A
Intended Use / Indications for Use
The Jemo Spine, LLC, DELTA™, Spinal Fusion System, a posterior spinal fixation device is a pedicle screw system indicated 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 Jemo Spine, LLC, DELTAT™, Spinal Fusion System 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).
When used as an posterior screw fixation system such as a sacral/iliac screw fixation system, the Jemo Spine, LLC, DELTA™, Spinal Fusion System is indicated for patients with severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.
Product codes
MNI, MNH, KWQ
Device Description
The Jemo Spine, LLC, DELTA™, Spinal Fusion System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, cap/set screws, and a transverse (cross) linking mechanism. The Jemo Spine, LLC, DELTA1", Spinal Fusion System implant components are fabricated from titanium allov (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.
The Jemo Spine, LLC, DELTA™, Spinal Fusion System can be used in the posterior plane providing unilateral and bilateral modes of fixation.
The Jemo Spine, LLC, DELTA™, Spinal Fusion System design allows adjustment in both the sagittal and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation. This is accomplished by means of a preassembled bi-polar cup and internal saddle in the housing component between the screw and the rod which tightens against the head of the pedicle screw upon interface of the cap/set screw assembly with the rod.
Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Jemo Spine, LLC, DELTAT™, Spinal Fusion System implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and sacral spine (L3 to sacrum), thoracic, lumbar and sacral spine, L5-S1 vertebra
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
Mechanical testing included static and fatigue testing performed per ASTM F 1717-04. No clinical tests were conducted on the subject system or the predicate system. The subject device was found substantially equivalent to the predicate device for all performance, safety & effectiveness requirements.
Key Metrics
Not Found
Predicate Device(s)
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
K071857
Page 1 of 3
510(k) SUMMARY
K071857 - 510 (K) Premarket Notification
AUG - 8 2007
Jemo Spine, LLC, DELTA™, Spinal Fusion System
1. Submitter/Sponsor:
Jemo Spine, LLC, 6170 South 380 west Suite 200. Murray, Utah. 84107 Contact person: Patrick Moore Vice-President , Jemo Spine, LLC. Tel: 801-266-4811; Fax: 801-255-4363 Date Prepared: July 30th, 2007
2. Device Name:
Proprietary/Trade Name: Jemo Spine, LLC, DELTA™, Spinal Fusion System Pedicle Screw Spinal System Common/Usual Name: Pedicle Screw Spinal System Classification Name:
3. Device Classification(s):
Class II (88.3390) following Orthopedic and Rehabilitation Device Advisory Review, for the requested indications:
- Spinal Pedicle Screw (MNI) 21 CFR § 888.3070 .
- Spondylolisthesis Spinal Fixation Device System (MNH) 21 CFR § 888.3070 .
- Spinal Intervertebral Body Fixation Orthosis (KWQ) 21 CFR § 888.3060 .
4. Predicate Device:
U&I Corporation, OPTIMA™ Spinal System -- MNH, MNI, KWQ -- (K020279 and K024096)
5. Device Description:
The Jemo Spine, LLC, DELTA™, Spinal Fusion System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, cap/set screws, and a transverse (cross) linking mechanism. The Jemo Spine, LLC, DELTA1", Spinal Fusion System implant components are fabricated from titanium allov (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.
The Jemo Spine, LLC, DELTA™, Spinal Fusion System can be used in the posterior plane providing unilateral and bilateral modes of fixation.
The Jemo Spine, LLC, DELTA™, Spinal Fusion System design allows adjustment in both the sagittal and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation. This is accomplished by means of a preassembled bi-polar cup and internal saddle in
the housing component between the screw and the rod which tightens against the head
1
107185
of the pedicle screw upon interface of the cap/set screw assembly with the rod.
Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Jemo Spine, LLC, DELTAT™, Spinal Fusion System implants.
From the foregoing, we conclude that the subject Jemo Spine, LLC, DELTA™, Spinal Fusion System device is as safe and effective as named predicate and currently marketed competitive devices for the stated indications.
6. Indications for Use:
The Jemo Spine, LLC, DELTA™, Spinal Fusion System, a posterior spinal fixation device is a pedicle screw system indicated 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 Jemo Spine, LLC, DELTA™, Spinal Fusion System 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).
When used as an posterior screw fixation system such as a sacral/iliac screw fixation system, the Jemo Spine, LLC, DELTA™, Spinal Fusion System is indicated for patients with severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.
- Comparison with predicate device: Jemo Spine, LLC, DELTATM, Spinal Fusion System is substantially equivalent to the currently marketed OPTIMA™ Spinal System
When considered for anterior applications, both the DELTA™ Spinal Fusion System and the OPTIMA™ Spinal System worst case constructs consist of a universal housing containing a pre-assembled pedicle screw and set screw; (DELTA™), Spinal Fusion System employs a proximal-cap/set-screw assembily). Both systems use a vertical rods (DELTATM Spinal Fusion System uses a 5.5mm rod and the OPTIMA™ Spinal System uses 6.0mm diameter rod) which are both placed into the housing. The
proximal cap/set screw assembly for the DELTA™ Spinal Fusion System and only a set screw with OPTIMA ™ Spinal System are subsequently tightened onto the rod, providing a completed implant assembly.
The principles of operation for the subject JEMO SPINE, LLC. DELTA™ Spinal Fusion Systemdevice, and the cited predicate technologies are similar. That is, each of these products employs similar indications for use, contraindications for use, warnings and precautions within labeling. The principles of operation of the subject device are directly equivalent to those of the cited predicates cleared by the Agency and currently being marketed.
The target populations on which product usage would occur for the subject device shall
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Page 3 of 3
remain similar / equivalent to those of the cited predicate products.
A properly placed pedicle is fully seated against the vertebral body, rendering the largest prominence the housing / seated set screw. The largest width is the largest diameter of the housing component.
Matrix 1
| Component(s) | Dimension | DeltaTM | OptimaTM |
|---|---|---|---|
| Universal Housing | Height | 0.670" | 0.680" |
| Universal Housing | O.D. / Implant Width | 0.540" | 0.550" |
| Pedicle Screw / Housing / Rod / Set Screw | Implant Height / Prominence | 0.690" | 0.690" |
As shown in the above matrix 1, the height and width in the Optima™ is ~0.010" larger than in the DELTA™ Spinal Fusion System; in side by side comparison, the Overall prominence height in the Optima™ is equal to the DELTA™ Spinal Fusion System.
(The term "substantial Equivalence" is used only as it is defined in the Medical Device Amendment of 1976 as amended by the Safe Medical Device Act of 1990 and is not intended to, nor does it refer to, the definition of substantial equivalence in the U.S. or any other patent law.)
The design and development process of the manufacturer of subject system and Predicate system conforms to 21 CFR part 820, ISO 9001 and ISO 13485 quality systems.
Both the subject device and the predicate device were evaluated/tested per established requirements. The mechanical testing included static and fatique testing performed per ASTM F 1717-04.
Clinical tests: No clinical tests conducted on either the subject system nor the predicate system.
Conclusion: The subject device was evaluated against the predicate device for all performance, safety & effectiveness requirements and found as substantially equivalent to the predicate device.
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-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2007
Jemo Spine, LLC % Mr. Patrick Moore Vice President 6170 South 380 West Suite 200 Murray, Utah 84107
Re: K071857
Trade/Device Name: Jemo Spine DELTA™ Spinal Fusion System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWQ Dated: June 27, 2007 Received: July 5, 2007
Dear Mr. Moore:
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. Iisting 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 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. Patrick Moore
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Oarlare Buehu
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
SECTION II
INDICATIONS for USE STATEMENT
510(k) Number (if known): K071857
Device Name: Jemo Spine, LLC, DELTA™, Spinal Fusion System.
Indications for Use: The Jemo Spine, LLC, DELTA™, Spinal Fusion System, a posterior spinal fixation device is a pedicle screw system indicated 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 Jemo Spine, LLC, DELTAT™, Spinal Fusion System 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).
When used as an posterior screw fixation system such as a sacral/iliac screw fixation system, the Jemo Spine, LLC, DELTA™, Spinal Fusion System is indicated for patients with severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.
Prescription Use______________________________________________________(Per 21 CFR 801.109) (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara buchner
Division of General, Restorative. and Neurological Devices
510(k) Number K071857