(93 days)
Not Found
No
The summary describes a physical interbody fusion device and its associated hardware and instruments. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies are based on mechanical testing and cadaveric studies, not data analysis or image processing.
Yes
The device is described as an "interbody fusion device" intended for "use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1)", which indicates its purpose is to treat a medical condition.
No
Explanation: This device is an interbody fusion device, specifically spacers used in spinal fusion surgery. Its purpose is to aid in fusing vertebrae, not to diagnose medical conditions.
No
The device description clearly states it is an interbody fusion device made from titanium alloy, which is a physical hardware component. The summary also describes screws, anchors, locking plates, and instruments, all of which are hardware. There is no mention of software as the primary or sole component of the device.
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 described as lumbar interbody fusion devices, which are implants used in spinal surgery. They are physical devices inserted into the body.
- Intended Use: The intended use clearly states that these devices are for surgical implantation in patients with degenerative disc disease to promote spinal fusion. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
The text focuses on the mechanical properties, surgical use, and implantation of the device, which are characteristic of a medical device used for treatment, not an IVD used for diagnosis.
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 sketally 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 and/or Anchors:
When used with three (3) anchors, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 level without the need for supplemental fixation.
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 without the need for supplemental fixation.
Hyperlordotic interbody devices (>20° lordosis) used with screws and/or anchors must always be used with supplemental fixation and may be used at 1 or 2 contiguous levels.
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 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.
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 and/or anchors, these devices are standalone interbody fusion devices. The integrated fixation anchors may not provide adequate stability for all situations. The surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g., anterior plate, posterior pedicle screws) may be needed. When used without screws and/or anchors, 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-6AI-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, 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, cadaveric Range of Motion (ROM), cadaveric fatigue studies, and void analysis compared to a previously cleared predicate device.
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.
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
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February 10, 2023
Osseus Fusion Systems % Ms. Jennifer Palinchik President JALEX Medical LLC 27865 Clemens Rd Suite 3 Westlake, Ohio 44145
Re: K223413
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 Dated: January 18, 2023 Received: January 30, 2023
Dear Ms. Palinchik:
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
1
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@fda.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
2
Indications for Use
510(k) Number (if known) K223413
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 sketally 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 and/or Anchors:
When used with three (3) anchors, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 level without the need for supplemental fixation.
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 without the need for supplemental fixation.
Hyperlordotic interbody devices (>20° lordosis) used with screws and/or anchors must always be used with supplemental fixation and may be used at 1 or 2 contiguous levels.
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 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
Image /page/4/Picture/1 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 rounded edges. The color of the letters transitions from purple to blue. There is a trademark symbol next to the last letter.
510(k) Summary
| Submitted By: | Osseus Fusion Systems
1931 Greenville Ave.
Suite 200
Dallas, TX 75206 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Date: | 02/08/2023 |
| Contact Person: | Jennifer Palinchik, JALEX Medical, President (consultant) |
| Contact Telephone: | (440) 935-3282 |
| Contact Fax: | (440) 933-7839 |
| Device Trade Name: | PISCES™-SA STANDALONE ALIF Interbody System |
| Device Classification Name: | Intervertebral Body Fusion Device with Integrated Fixation, Lumbar |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Product Code: | OVD, MAX, PHM |
| Predicate Device: | K213935- PISCES™-SA STANDALONE ALIF Interbody System
The predicate device has 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 and/or anchors, these devices are standalone interbody fusion devices. The integrated fixation anchors may not provide adequate stability for all situations. The surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g., anterior plate, posterior pedicle screws) may be needed. When used without screws and/or anchors, 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-6AI-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, 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™S A (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-Sl). 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. 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 and/or Anchors:
5
- When used with three (3) anchors, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 level without the need for supplemental fixation. -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 without the need for supplemental fixation.
-Hyperlordotic interbody devices (>20° lordosis) used with screws and/or anchors must always be used with supplemental fixation and may be used at 1 or 2 contiguous levels.
PISCESTM ALIF Spacers (Without Integrated Fixation) .
PISCES™ ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (TI-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (LI-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.
6
തടടലടച
Summary of Technological Characteristics:
| Table 1: Technological Characteristics Comparison | ||
|---|---|---|
| -- | --------------------------------------------------- | -- |
| Feature | Subject Device:
PISCES™-SA
Standalone ALIF
Interbody System | Primary Predicate:
K213935 -PISCES™-
SA Standalone ALIF
Interbody System | Comparison |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Regulation | 888.3080 | 888.3080 | Equivalent |
| Product Code | OVD, MAX, PHM | OVD, MAX, PHM | Equivalent |
| Indications for Use | PISCES™-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
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. | PISCES™-SA
Standalone ALIF
Interbody System is a
family of integrated
interbody fusion devices
indicated for one or
more contiguous 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), up to
Grade 1
spondylolisthesis or
retrolisthesis at involved
level(s), deformity
(degenerative scoliosis
or kyphosis), spinal
stenosis, and failed
previous fusion
(pseudarthrosis). DDD is
defined as a 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 (6)
months of non-operative
treatment.
PISCES™-SA
Standalone ALIF | Equivalent |
| | PISCES™-SA Used with
Screws and/or Anchors:
-When used with three (3)
anchors, interbody devices
with a lordotic angle ≤20° | | |
7
.
| can be used as
standalone interbody
fusion devices at 1 level
without the need for
supplemental fixation.
-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
without the need for
supplemental fixation.
-Hyperlordotic interbody
devices (>20° lordosis)
used with screws and/or
anchors must always be
used with supplemental
fixation and may be used
at 1 or 2 contiguous
levels.
PISCES™ ALIF Spacers
(Without Integrated
Fixation)
PISCES™ ALIF Spacers
are lumbar interbody
fusion devices indicated
at one or more levels of
the thoracic spine (Tl-
T12), thoracolumbar
junction (T12-Ll), or
lumbosacral spine (Ll-Sl)
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. | Interbody System is
intended to be used with
or without three screws
or anchors which
accompany the
interbodies. When used
with screws, these
devices are standalone
interbody fusion devices
for one or two
contiguous levels of the
lumbosacral spine (L1-
S1). When used with
anchors, these devices
are stand-alone
interbody fusion devices
for one level of the
lumbosacral spine (L1-
S1). When used without
screws or anchors, these
devices are intended for
use with supplemental
fixation (e.g. facet
screws or posterior
fixation) for one or more
contiguous levels of the
thoracic spine (T1-T12,
thoracolumbar junction
(T12-L1), or
lumbosacral spine (L1-
S1). When used without
screws or anchors, these
devices with ≥ 20°
lordosis must be used
with at least anterior
supplemental fixation.
PISCES™-SA
Standalone ALIF
Interbody System is
designed for use with
autograft and/or
allogenic bone graft
composed of cancellous
and/or corticocancellous
bone graft to facilitate
fusion. |
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
8
തടടലടന
| 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 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 | PISCESTM-SA | Equivalent |
| Standalone ALIF spacers | Standalone ALIF | ||
| are interbody fusion | spacers are interbody | ||
| devices for the lumbar | fusion devices for the | ||
| spine that may be used | lumbar spine that may | ||
| with three titanium alloy | be used with three | ||
| screws or anchors which | titanium alloy screws or | ||
| accompany the implants. | anchors which | ||
| When used with screws | accompany the implants. | ||
| and/or anchors, these | When used with screws | ||
| devices are standalone | and/or anchors, these | ||
| interbody fusion devices. | devices are standalone | ||
| When used without | interbody fusion | ||
| screws and/or anchors, | devices. When used | ||
| these devices are intended | without screws and/or | ||
| for use with supplemental | anchors, these devices | ||
| fixation (e.g. facet screws | are intended for use with | ||
| or posterior fixation). The | supplemental fixation | ||
| PISCESTM-SA spacers | (e.g. facet screws or | ||
| are manufactured from | posterior fixation). The | ||
| titanium alloy (Ti-6Al-4V | PISCESTM-SA spacers | ||
| ELI) per ASTM F3001. | are manufactured from | ||
| 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, | |||
| blocking plates, and | |||
| instruments are supplied | |||
| in a re-usable tray for | |||
| steam sterilization. | 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, | |||
| blocking plates, and | |||
| instruments are supplied | |||
| in a re-usable tray for | |||
| steam sterilization. | |||
| Interbody Heights | 9-19 mm in 2 mm | ||
| increments | 9-19 mm in 2 mm | ||
| increments | Equivalent | ||
| Footprints | 23x29 mm, 26x35 mm, | ||
| 29x39 mm | 23x29 mm, 26x35 mm, | ||
| 29x39 mm | Equivalent | ||
| Lordotic Angles | 8°, 16°, 20°, 24° | 8°, 16°, 20°, 24° | Equivalent |
| Standalone Fixation | |||
| Technology | Screws or Anchors | Screws or Anchors | Equivalent |
| Screw Diameters | Ø4.8 mm and Ø5.25 mm | Ø4.8 mm and Ø5.25 mm | Equivalent |
| Screw Lengths | 15-52.5 mm in 2.5 mm | ||
| increments | 15-52.5 mm in 2.5 mm | ||
| increments | Equivalent | ||
| Screw Types | Fixed, Variable, Self- | ||
| tapping, Self-drilling | Fixed, Variable, Self- | ||
| tapping, Self-drilling | Equivalent | ||
| Anchor Diameter | Ø4.8 mm | Ø4.8 mm | Equivalent |
| Anchor Lengths | 22.5 mm, 25 mm, 27.5 | ||
| mm | 22.5 mm, 25 mm, 27.5 | ||
| mm | Equivalent | ||
| Materials | Ti-6Al-4V ELI per | ||
| ASTM F3001 and ASTM | |||
| F136 | Ti-6Al-4V ELI per | ||
| ASTM F3001 and | |||
| ASTM F136 | Equivalent |
9
Oss=us™
10
Image /page/10/Picture/0 description: The image shows the word "OSSEUS" in a stylized font. The word is written in a gradient of colors, starting with purple on the left and fading to blue on the right. The letters are rounded and have a modern look. There is a trademark symbol in the upper right corner of the word.
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, cadaveric Range of Motion (ROM), cadaveric fatigue studies, and void analysis compared to a previously cleared predicate device.
Conclusion:
Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.