(141 days)
Not Found
No
The document describes a physical interbody fusion device and its mechanical properties and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an interbody fusion device intended for use in patients with degenerative disc disease, disc herniation, spondylolisthesis, deformity, and spinal stenosis. These are conditions that cause pathology and the device is used to treat those pathologies.
No
The device is an interbody fusion device intended for use in spinal fusion surgeries to treat various spinal conditions. It is a surgical implant designed to provide stability and promote fusion, not to diagnose medical conditions.
No
The device description clearly states it is an interbody fusion device manufactured from titanium alloy, along with accompanying screws, anchors, and instruments. This indicates it is a physical medical device, not software-only.
Based on the provided text, 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.
- Device Description: The PISCES™-SA ALIF Spacers are physical implants made of titanium alloy, designed to be surgically inserted into the spine to facilitate fusion.
- Intended Use: The intended use is for treating degenerative disc disease and other spinal conditions by providing structural support and promoting bone fusion. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
PISCESTM-SA ALIF Spacers (Standalone Use. With Integrated Fixation)
The PISCES™ SA (Standalone) ALIF Interbody System are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ SA (Standalone) ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
PISCESTM-SA Used With Screws: When used with three (3) screws, interbody devices with a lordotic angle 20° lordosis) used with screws, must always be used with supplemental fixation, and may be used at 1 or 2 levels.
PISCESTM-SA Used With Anchors When used with three (3) anchors, these devices can be used as interbody fusion devices at 1 or 2 levels and must always be used with supplemental fixation.
PISCESTM ALIF Spacers (Without Integrated Fixation)
PISCESTM ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudatthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (200 lordosis) must be used with at least anterior supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
OVD, MAX, PHM
Device Description
PISCES™-SA Standalone ALIF Interbody System is an interbody fusion device for the lumbar spine that may be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are standalone interbody fusion devices. When used with anchors or without screws, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The PISCES" -SA interbodies are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The spacers are available in multiple sizes. The spacers are single use devices, which are sterilized via gamma radiation and are provided to the user in sterile packages. The screws, anchors, and locking plates are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and must be sterilized prior to use. The instruments used to insert the cage are manufactured from medical grade stainless steel and must be sterilized prior to use. The screws, anchors, locking plates, and instruments are supplied in a re-usable tray for steam sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine (L2-S1), thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1)
Indicated Patient Age Range
skeletally mature
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)
Substantial equivalence is supported by the results of mechanical testing including static and dynamic compression per ASTM F2077, static and dynamic compression shear per ASTM F2077, subsidence per ASTM F2267, expulsion testing, cantilever anchor bending, and anchor impaction testing. Substantial equivalence is also supported by performing cadaveric implantation and cadaveric Range of Motion (ROM) studies.
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.
K191391 - Globus HEDRON Lumbar Spacers, K181347 - Osseus ARIES Lumbar Interbodies, K153495 - Zimmer ROI-A ALIF Cage System, K203742 - Alphatec IdentiTiTM ALIF Standalone Interbody System, K192121 - Black Diamond Pedicle Screw System
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 6, 2022
Osseus Fusion Systems % Daniel Johnson Regulatory Engineer Jalex Medical LLC 27865 Clemens Rd Suite 3 Westlake, Ohio 44145
Re: K213935
Trade/Device Name: PISCES™-SA Standalone ALIF Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX, PHM
Dear Daniel Johnson:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 6, 2022. Specifically, FDA is updating this SE Letter to correct the product code as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Brent Showalter, Ph.D., OHT6: Office of Orthopedic Devices, (240) 402-1840, Brent.Showalter@fda.hhs.gov.
Sincerely,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two distinct elements: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized depiction of a human figure, while the FDA portion includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font and "ADMINISTRATION" in a smaller font below.
May 6, 2022
Osseus Fusion Systems % Daniel Johnson Regulatory Engineer Jalex Medical LLC 27865 Clemens Rd Suite 3 Westlake, Ohio 44145
Re: K213935
Trade/Device Name: PISCES™-SA Standalone ALIF Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX, PHH Dated: April 26, 2022 Received: April 27, 2022
Dear Daniel Johnson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
2
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K213935
Device Name PISCESTM_SA Standalone ALIF Interbody System
Indications for Use (Describe)
PISCESTM-SA ALIF Spacers (Standalone Use. With Integrated Fixation)
The PISCES™ SA (Standalone) ALIF Interbody System are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ SA (Standalone) ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
· PISCESTM-SA Used With Screws:
When used with three (3) screws, interbody devices with a lordotic angle 20° lordosis) used with screws, must always be used with supplemental fixation, and may be used at 1 or 2 levels.
· PISCESTM_SA Used With Anchors
When used with three (3) anchors, these devices can be used as interbody fusion devices at 1 or 2 levels and must always be used with supplemental fixation.
PISCESTM ALIF Spacers (Without Integrated Fixation)
PISCESTM ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudatthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (200 lordosis) must be used with at least anterior supplemental fixation.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
This section applies only to requirements of the Paperwork Reduction Act of 1995,
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
Image /page/5/Picture/0 description: The image shows the logo for OSSEUS. The logo is in a gradient of purple and blue. The logo consists of a square with a circle inside of it, followed by the text "OSSEUS" in a sans-serif font. The letters are in a gradient of purple and blue, with the left side of the letters being purple and the right side being blue.
510(k) Summary
| Submitted By: | Osseus Fusion Systems
1931 Greenville Ave.
Suite 200
Dallas, TX 75206 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 12/14/21 |
| Contact Person:
Contact Telephone:
Contact Fax: | Daniel Johnson, Regulatory Engineer
(440) 541-0060
(440) 933-7839 |
| Device Trade Name:
Device Classification Name:
Device Classification:
Reviewing Panel:
Product Code:
Predicate Device:
Additional Predicates: | PISCESTM-SA STANDALONE ALIF Interbody System
Intervertebral Body Fusion Device with Integrated Fixation, Lumbar
Class II
Orthopedic
OVD, MAX, PHM
K191391 - Globus HEDRON Lumbar Spacers
K181347 - Osseus ARIES Lumbar Interbodies
K153495 - Zimmer ROI-A ALIF Cage System
K203742 - Alphatec IdentiTiTM ALIF Standalone Interbody System
K192121 - Black Diamond Pedicle Screw System |
The predicate devices have not been subject to any design related recalls.
Device Description:
PISCES™-SA Standalone ALIF Interbody System is an interbody fusion device for the lumbar spine that may be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are standalone interbody fusion devices. When used with anchors or without screws, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The PISCES" -SA interbodies are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The spacers are available in multiple sizes. The spacers are single use devices, which are sterilized via gamma radiation and are provided to the user in sterile packages. The screws, anchors, and locking plates are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and must be sterilized prior to use. The instruments used to insert the cage are manufactured from medical grade stainless steel and must be sterilized prior to use. The screws, anchors, locking plates, and instruments are supplied in a re-usable tray for steam sterilization.
Intended Use:
PISCESTM-SA ALIF Spacers (Standalone Use, With Integrated Fixation)
The PISCES™-SA (Standalone) ALIF Interbody System are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and
6
have had at least six (6) months of non-operative treatment. PISCES™-SA (Standalone) ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
- o PISCES™-SA Used With Screws:
When used with three (3) screws, interbody devices with a lordotic angle ≤ 20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels.
Hyperlordotic interbody devices (>20° lordosis) used with screws, must always be used with supplemental fixation, and may be used at 1 or 2 levels.
- PISCESTM-SA Used With Anchors ● When used with three (3) anchors, these devices can be used as interbody fusion devices at 1 or 2 levels and must always be used with supplemental fixation.
PISCESTM ALIF Spacers (Without Integrated Fixation)
PISCES™ ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation.
Summary of Technological Characteristics:
PISCES™-SA Standalone ALIF Interbody System and the predicates have the same intended use and fundamental scientific technology. All devices compare similarly in:
- Design features ●
- Intended use ●
- . Materials
- Dimensions ●
- Function .
Please see Table 1 Below for a comparison of the devices. The Globus HEDRON information was gathered from the system's surgical technique and marketing information.
7
Summary of Technological Characteristics
'able 1: Technological Characteristics Comparison
| Feature | Subject Device: PISCESTM-SA Standalone ALIF Interbody System | Primary Predicate: K191391-Globus HEDRON Lumbar Spacers | Comparison |
|---|---|---|---|
| Regulation | 888.3080 | 888.3080 | Equivalent |
| Product Code | OVD, MAX, PHM | MAX, OVD, PHM | Equivalent |
| Indications for Use | PISCESTM-SA ALIF Spacers | ||
| (Standalone Use, With Integrated Fixation) | |||
| The PISCESTM-SA (Standalone) ALIF Interbody System are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCESTM-SA (Standalone) ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. | HEDRONTM Lumbar Spacers | ||
| (HEDRON ATM, HEDRON LTM, HEDRON PTM, HEDRON TTM, and HEDRON RTTM) are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. HEDRONTM Spacers | Equivalent | ||
| • PISCESTM-SA Used With | |||
| Screws: | |||
| When used with three (3) | |||
| screws, interbody devices | |||
| with a lordotic angle ≤ | |||
| 20° can be used as | |||
| standalone interbody | |||
| fusion devices at 1 or 2 | |||
| contiguous levels. | are to be filled with autograft | ||
| bone and/or allogenic bone graft | |||
| composed of cancellous and/or | |||
| corticocancellous bone. These | |||
| devices are intended to be used | |||
| with supplemental fixation | |||
| systems that have been cleared | |||
| for use in the thoracolumbosacral | |||
| spine (e.g., posterior pedicle | |||
| screw and rod systems, anterior | |||
| plate systems, and anterior screw | |||
| and rod systems). Hyperlordotic | |||
| interbody devices (≥20° lordosis) | |||
| must be used with at least anterior | |||
| supplemental fixation. | HEDRON IAT™ Integrated | ||
| Lumbar Spacers are integrated | |||
| lumbar interbody fusion devices | |||
| intended for use in patients with | |||
| degenerative disc disease (DDD) | |||
| at one or two contiguous levels of | |||
| the lumbosacral spine (L2-S1). | |||
| DDD is defined as discogenic | |||
| back pain with degeneration of | |||
| the disc confirmed by history and | |||
| radiographic studies. These | |||
| patients should be skeletally | |||
| mature and have had at least six | |||
| (6) months of non-operative | |||
| treatment. In addition, these | |||
| patients may have up to Grade 1 | |||
| spondylolisthesis or retrolisthesis | |||
| at the involved level(s). | |||
| HEDRON IAT™ Spacers are to be | |||
| filled with autograft bone and/or | |||
| Hyperlordotic interbody | |||
| devices (>20° lordosis) | |||
| used with screws, must | |||
| always be used with | |||
| supplemental fixation, | |||
| and may be used at 1 or 2 | |||
| levels. | |||
| • PISCESTM-SA Used With | |||
| Anchors | |||
| When used with three (3) | |||
| anchors, interbody | |||
| devices with a lordotic | |||
| angle ≤ 20° can be used | |||
| as standalone interbody | |||
| fusion devices at 1 or 2 | |||
| levels. | |||
| Hyperlordotic interbody | |||
| devices (>20° lordosis) | |||
| used with anchors, must | |||
| always be used with | |||
| supplemental fixation, | |||
| allogenic bone graft composed of | |||
| cancellous and/or | PISCESTM ALIF Spacers | ||
| (Without Integrated Fixation) | |||
| PISCESTM ALIF Spacers are | |||
| lumbar interbody fusion devices | |||
| indicated at one or more levels of | |||
| the thoracic spine (T1-T12), | |||
| thoracolumbar junction (T12-L1), | |||
| or lumbosacral spine (L1-S1) as | |||
| an adjunct to fusion in patients | |||
| with the following indications: | |||
| degenerative disc disease (DDD), | |||
| disc herniation (with myelopathy | |||
| and/or radiculopathy), | |||
| spondylolisthesis, deformity | |||
| (degenerative scoliosis or | |||
| kyphosis), spinal stenosis, and | |||
| failed previous fusion | |||
| (pseudarthrosis). DDD is defined | |||
| as discogenic back pain with | |||
| degeneration of the disc as | |||
| confirmed by history and | |||
| radiographic studies. These | |||
| patients should be skeletally | |||
| mature and have had at least six | |||
| (6) months of non-operative | |||
| treatment. PISCESTM ALIF | |||
| Spacers are to be filled with | |||
| autograft bone and/or allogenic | |||
| bone graft composed of | |||
| cancellous and/or | |||
| corticocancellous bone. These | |||
| devices are intended to be used | |||
| with supplemental fixation | |||
| systems that have been cleared | |||
| and may be used at 1 or 2 | |||
| levels. | corticocancellous bone. These | ||
| devices are intended to be used | |||
| with three screws or anchors | |||
| which accompany the implants. | |||
| When used with screws, these | |||
| devices are stand-alone interbody | |||
| fusion devices. When used with | |||
| anchors, these devices are | |||
| intended for use with | |||
| supplemental fixation (e.g. facet | |||
| screws or posterior fixation). | |||
| Hyperlordotic implants (≥25° | |||
| lordosis) are intended for use with | |||
| supplemental fixation (e.g. facet | |||
| screws or posterior fixation). | |||
| When used without screws or | |||
| anchors, these devices are | |||
| intended for use with | |||
| supplemental fixation (e.g. facet | |||
| screws or posterior fixation). |
Page 3 of 8
8
ම් ග්රිය පිටි කිරීම ප්රධාන අවස්ථාන මිත කිරීම සිට පිහිටි මිත කිරීම සිට පිහිටි මිත කිරීම පිහිටි මිත කිරීම පිහිටි මිත කිරීම පිහිටි මිත කිරීම පිහිටි මිත කිරීම පිහිටි මිත කිරීම
Page 4 of 8
9
ම් ග්රිය පිහිටි පිහිටි පිහිටි බව පිහිටි පිහිටි පිහිටි බව පිහිටි පිහිටි බව පිහිටි පිහිටි පිහිටි බව පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි මිනිස් පිහිටි මිනිස් පිහි
10
| | for use in the thoracolumbosacral
spine (e.g., posterior pedicle
screw and rod systems, anterior
plate systems, and anterior screw
and rod systems). Hyperlordotic
interbody devices (≥20° lordosis)
must be used with at least anterior
supplemental fixation. | | |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device Description | PISCESTM-SA Standalone ALIF
spacers are interbody fusion
devices for the lumbar spine that
may be used with three titanium
alloy screws or anchors which
accompany the implants. When
used with screws and/or anchors,
these devices are standalone
interbody fusion devices. When
used without screws and/or
anchors, these devices are
intended for use with
supplemental fixation (e.g. facet
screws or posterior fixation). The
PISCESTM-SA spacers are
manufactured from titanium alloy
(Ti-6Al-4V ELI) per ASTM
F3001. The spacers are available
in multiple sizes. The spacers are
single use devices, which are
sterilized via gamma radiation
and are provided to the user in
sterile packages. The screws,
anchors, and locking plates are
manufactured from titanium alloy
(Ti-6Al-4V ELI) per ASTM F136 | HEDRON Integrated Lumbar
Spacers are integrated anterior
lumbar interbody fusion devices
used to provide structural stability
following discectomy. They are
used with screws and/or anchors.
All HEDRON Lumbar Spacers
are additively manufactured from
titanium powder per ASTM
F3001. The mating screws and
anchors are manufactured from
titanium alloy, per ASTM F135
and F1295, and/or cobalt chrome
alloy, per ASTM F1567.
Titanium screws and anchors are
available with or without
hydroxyapatite (HA) coating, per
ASTM F1185. | Equivalent |
11
Osseus
| use. The instruments used to
insert the cage are manufactured
from medical grade stainless steel
and must be sterilized prior to
use. The screws, anchors,
blocking plates, and instruments
are supplied in a re-usable tray for
| steam sterilization. | |||
|---|---|---|---|
| Interbody Heights | 9-19 mm in 2 mm increments | 11-21 mm in 2 mm increments | Equivalent |
| Footprints | 23x29 mm, 26x35 mm, 29x39 mm | 24x30 mm, 26x34 mm, 29x39 mm | Equivalent |
| Lordotic Angles | 8°, 16°, 20°, 24° | 8°, 15°, 20°, 25°, 30° | Equivalent |
| Standalone Fixation | |||
| Technology | Screws or Anchors | Screws or Anchors | Equivalent |
| Screw Diameters | Ø4.8 mm and Ø5.25 mm | Ø5.5 mm | Equivalent |
| Screw Lengths | 15-52.5 mm in 2.5 mm | ||
| increments | 20-60 mm in 5 mm increments | Equivalent | |
| Screw Types | Fixed, Variable, Self-tapping, | ||
| Self-drilling | Fixed, Variable, Self-tapping, | ||
| Self-drilling | Equivalent | ||
| Anchor Diameter | Ø4.8 mm | Ø5.5 mm | Equivalent |
| Anchor Lengths | 22.5 mm, 25 mm, 27.5 mm | 20 mm, 25 mm, 27 mm, 30 mm, | |
| 35 mm, 40 mm | Equivalent | ||
| Materials | Ti-6Al-4V ELI per ASTM F3001 | ||
| and ASTM F136 | Ti-6Al-4V ELI per ASTM F3001, | ||
| Titanium alloy per ASTM F135 | |||
| and F1295, and/or cobalt chrome | |||
| alloy per ASTM F1537 | Equivalent |
12
Image /page/12/Picture/0 description: The image shows the word "OSSEUS" in a stylized font. The first letter, "O", is a square with a dot in the center. The rest of the letters are in a sans-serif font, with the "E" represented by three horizontal lines. The color of the text transitions from purple to blue.
Non-clinical Testing:
Substantial equivalence is supported by the results of mechanical testing including static and dynamic compression per ASTM F2077, static and dynamic compression shear per ASTM F2077, subsidence per ASTM F2267, expulsion testing, cantilever anchor bending, and anchor impaction testing. Substantial equivalence is also supported by performing cadaveric implantation and cadaveric Range of Motion (ROM) studies.
Conclusion:
Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.