(228 days)
Not Found
No
The device description focuses on mechanical components (hooks, screws, rods, connectors) and materials. There is no mention of software, algorithms, image processing, AI, ML, or performance studies related to such technologies.
Yes
The device is a spinal fixation system intended to immobilize and stabilize the spine as an adjunct to fusion for treating various spinal conditions, which are therapeutic actions.
No
The device is a spinal fixation system, intended for immobilization and stabilization of the spine as an adjunct to fusion, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the system consists of various hooks, screws, rods, and connectors, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the AnyPlus Spinal Fixation System is a "posterior pedicle screw fixation system," "posterior hook fixation system," or "anterolateral fixation system" used for "immobilization and stabilization of the spine as an adjunct to fusion." This describes a surgical implant used in vivo (within the body) to treat structural issues of the spine.
- Device Description: The device description details components like "hooks, screws, rods and connectors" made from materials like Ti6Al4V ELI. These are physical implants designed to be surgically placed in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to physically stabilize the spine.
N/A
Intended Use / Indications for Use
AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation system (T1-L5), or as a anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWP, KWQ, MNH, MNI, NKB
Device Description
The AnyPlus Spinal Fixation System consists of various hooks, screws, rods and connectors and is intended to create a rigid spinal construct. A table of components can be found in Section 11.
The AnyPlus Spinal Fixation System includes components from GSS Pedicle Screw System previously cleared in K053573. These components will keep their original cleared trade name. A table of components can be found in Section 11 identified as GSS Pedicle Screw System 510(k): K053573.
The components are manufactured from Ti6Al4V ELI according to ISO 5832-3 and ASTM F-136. The screws are available from 4.0 to 10.5mm diameters with lengths ranging from 20 to 100mm (Length does not include the screw head).
Specialized instruments are available for the application and removal of the Anypluss Spinal Fixation System. A table of components can be found in Section 11.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal (T1-S2), (T1-L5), (T8-L5)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 888.3070 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
·
Submitter: GS Medical Co., Ltd.
.
・
510(k) Summary
.
| Submitter Name:
Submitter Address: | GS Medical Co., Ltd
12 F Kolon Digital Tower Aston,
505-14Gasan-Dong,
Geumcheon-gu, Seoul, Korea | JAN 2 5 2010 |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Phone Number: | 82-2-2082-7777 | |
| Fax Number: | 82-2-2082-7778 | |
| Contact Person: | Dong Yong, Kim | |
| Date Prepared: | June 3, 2009 | |
| Device Trade Name: | AnyPlus Spinal Fixation System | |
| Common Name | Spinal interlaminal fixation orthosis
Spinal intervertebral body fixation orthosis
Pedicle Screw spinal system | |
| Classification Name, | Class II: appliance, fixation, spinal interlaminal, 888.3050, KWP | |
| Number &
Product Code: | Class II: appliance, fixation, spinal intervertebral body, 888.3060, KWQ | |
| | Class II/Class III: orthosis, spondyloisthesis spinal fixation, 888.3070,
MNH, MNI, NKB | |
| Predicate Devices: | GSS Pedicle Screw System (K053573),
Synthes Pangea System (K052123)
INCOMPASS SPINAL FIXATION SYSTEM (K021564) | |
| Device Description
and Statement of
Intended Use | Device Description: The AnyPlus Spinal Fixation System consists of
various hooks, screws, rods and connectors and is intended to create a
rigid spinal construct. A table of components can be found in Section 11. | |
| | The AnyPlus Spinal Fixation System includes components from GSS
Pedicle Screw System previously cleared in K053573. These
components will keep their original cleared trade name. A table of
components can be found in Section 11 identified as GSS Pedicle Screw
System 510(k): K053573. | |
| | The components are manufactured from Ti6Al4V ELI according to ISO
5832-3 and ASTM F-136. The screws are available from 4.0 to 10.5mm
diameters with lengths ranging from 20 to 100mm (Length does not
include the screw head). | |
| | Specialized instruments are available for the application and removal of
the Anypluss Spinal Fixation System. A table of components can be | |
| | Intended Use: AnyPlus Spinal Fixation System are non-cervical spinal fixation
devices intended for use as posterior pedicle screw fixation systems (T1-S2), a
posterior hook fixation system (T1-L5), or as a anterolateral fixation system (T8-
L5). All components in the system are limited to skeletally mature patients.
System components are to be used for immobilization and stabilization of the
spine as an adjunct to fusion. These devices are indicated for all of the following
indications regardless of the intended use: degenerative disc disease (defined
as discogenic back pain with degeneration of the disc confirmed by history and
radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation),
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis,
Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous
fusion | |
| Summary of
Technological
Characteristics | AnyPlus Spinal Fixation System is made of devices for fixation of the
non cervical spine. They include smooth rods, plates, screws, hooks, nut
screws, transverse links. The components are manufactured from
Ti6AI4V ELI according to ISO 5832-3 and ASTM F-136. The screws are
available from 4.0 to 10.5mm diameters with lengths ranging from 20 to
100mm (Length does not include the screw head). | |
| Conclusion | The information discussed above demonstrates that AnyPlus Spinal
Fixation System, as effective, and performs as well as or better than the
predicate devices. | |
| Declarations | This summary includes only information that is also covered in the body
of the 510(k).
This summary does not contain any puffery or unsubstantiated labeling
claims. | |
1
.
found in Section 11.
Summary of Technical Characteristics
| Feature | AnyPlus Spinal
Fixation System | GSS Pedicle Screw
System | Synthes Pangea
System | INCOMPASS
SPINAL FIXATION
SYSTEM |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K091717 | K053573 | K052123 | K021564 |
| Manufacturer | GS MEDICAL
CO., LTD. | GS MEDICAL CO.,
LTD. | SYNTHES
(USA) | SPINAL
CONCEPTS, INC |
| Classification # &
Product Code | 888.3050,
888.3060,
888.3070
KWP, KWQ, MNH,
MNI | 888.3070
MNH, MNI | 888.3050,
888.3070
KWP, KWQ,
MNH, MNI, NKB | 888.3060
KWP, KWQ, MNH,
MNI |
| Intended Use | AnyPlus Spinal
Fixation System
are non-cervical
spinal fixation
devices intended
for use as posterior
pedicle screw
fixation systems
(T1-S2), a
posterior hook
fixation system | The GSS Pedicle
Screw System is a
pedicle screw system
indicated for the
treatment of severe
Spondylisthesis
(Grade 3 and 4) of
the L5-S1 vertebra in
skeletally mature
patients receiving
fusion by autogenous | The Synthes USS
(including the
Click'X®, and
USS VAS variable
axis components,
and Pangea™),
Click'X®
Monoaxial, Dual-
Opening and the
Small Stature
USS (which | When intended for
pedicle screw
fixation from T1-S1,
the InCompass
Spinal Fixation
System is intended
to provide
immobilization and
stabilization of
spinal segments in
skeletally mature |
.
.
2
| (T1-L5), or as a
anterolateral
fixation system
(T8-L5). Pedicle
screw fixation is
limited to skeletally
mature patients.
These devices are
indicated for all of
the following
indications
regardless of the
intended use:
degenerative disc
disease (defined
as discogenic back
pain with
degeneration of
the disc confirmed
by history and
radiographic
studies),
spondylolisthesis,
trauma (i.e.,
fracture or
dislocation),
deformities or
curvatures (i.e.,
scoliosis, kyphosis,
and/or lordosis,
Scheuermann's
Disease), tumor,
stenosis,
pseudoarthrosis,
and failed previous
fusion. | | bon 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 GSS
Pedicle Screw
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). | | includes small
stature and
pediatric patients)
are non-cervical
spinal fixation
devices intended
for use as
posterior pedicle
screw fixation
systems (T1-S2),
a posterior hook
fixation system
(T1-L5), or as a
anterolateral
fixation system
(T8-L5). Pedicle
screw fixation is
limited to
skeletally mature
patients with the
exception of the
Small Stature
USS. These
devices are
indicated for all of
the following
indications
regardless of the
intended use:
degenerative disc
disease (defined
as discogenic
back pain with
degeneration of
the disc confirmed
by history and
radiographic
studies),
spondylolisthesis,
trauma (i.e.,
fracture or
dislocation),
deformities or
curvatures (i.e.,
scoliosis,
kyphosis, and/or
lordosis,
Scheuermann's
Disease), tumor,
stenosis,
pseudoarthrosis,
and failed
previous fusion.
When treating
patients with
Degenerative Disc
Disease (DDD), | transverse bars are not cleared for use as part of the posterior pedicle | 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 disc
disease (defined as
discogenic back
pain with
degeneration of the
disc confirmed by
history and
radiographic
studies),
degenerative
spondylolisthesis
with objective
evidence of
neurologic
impairment,
fracture, dislocation,
deformities or
curvatures (i.e.,
scoliosis, kyphosis,
and/or lordosis),
tumor, and failed
previous fusion.
As a pedicle screw
system placed
between L3 and S1,
the indications
include Grade 3 and
4 spondylolisthesis,
when utilizing
autologous bone
graft, when affixed
to the posterior
lumbosacral spine,
and intended to be
removed after solid
fusion is
established.
When intended for
non-pedicle,
posterior screw
fixation of the non-
cervical spine (T1-
S1), the indications
are idiopathic
scoliosis,
neuromuscular
scoliosis/kyphoscoli
osis with associated | paralysis or spasticity, scoliosis with deficient posterior elements |
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------- |
|---|
.
3
・
AnyPlus Spinal Fixation System Premarket Notification: Traditional 510(k)
| | screw construct. | such as that
resulting from | | | |
|--|-------------------|--------------------------------|--|---------------|---------------------------------------------------------|
| | When used with | laminectomy or | | | |
| | the 3.5/6.0 mm | myelomeningocele, | | | |
| | parallel | spinal fractures | | | |
| | connectors, the | (acute reduction or | | | |
| | Synthes USS | late deformity), | | | |
| | (including the | degenerative disc | | | |
| | Click'X® and, | disease (back pain | | | |
| | USS VAS variable | of discogenic origin | | | |
| | axis components, | with degeneration of | | | |
| | and Pangea™), | the disc confirmed | | | |
| | Click'X® | by history and | | | |
| | Monoaxial and | radiographic | | | |
| | Dual-Opening | studies), tumor, | | | |
| | USS can be linked | spondylolisthesis, | | | |
| | to the CerviFix® | spinal stenosis and | | | |
| | System. In | failed previous | | | |
| | addition, when | fusion. | | | |
| | used with 3.5/5.0 | | | | |
| | mm parallel | When intended for | | | |
| | connectors, the | anterolateral screw, | | | |
| | Synthes Small | rod and or cable | | | |
| | Stature USS can | fixation of the T6-L5 | | | |
| | be linked to the | spine the indications | | | |
| | Synthes USS | are degenerative | | | |
| | (including the | disc disease | | | |
| | Click'X®, and | disease (back pain | | | |
| | USS VAS variable | of discogenic origin | | | |
| | axis components, | with degeneration of | | | |
| | and Pangea™), | the disc confirmed | | | |
| | the Click'X® | by history and | | | |
| | Monoaxial and | radiographic | | | |
| | Dual-Opening | studies), | | | |
| | USS Systems. | spondylolisthesis, | | | |
| | | trauma (i.e. fracture | | | |
| | In addition, | or dislocation), | | | |
| | Synthes USS | spinal stenosis, | | | |
| | (including the | deformities or | | | |
| | Click'X®, and | curvatures (i.e. | | | |
| | USS VAS variable | scoliosis, kyphosis, | | | |
| | axis components, | and/or lordosis), | | | |
| | and Pangea), | tumor and failed | | | |
| | Click'X® | previous fusion. | | | |
| | Monoaxial and | | | | |
| | the Dual-Opening | The use of posterior | | | |
| | USS can be | spinal | | | |
| | interchanged with | instrumentation in | | | |
| | all USS 6.0 mm | children has been | | | |
| | rods and | reported in the | | | |
| | transconnectors. | literature. The | | | |
| | | InCompass Spinal | | | |
| | | Fixation System | | | |
| | | may be used for | | | |
| | | non-pedicle | | | |
| | | posterior use in this | | | |
| | | patient group. | | | |
| | | After solid fusion | | | |
| | | | | occurs, these | occurs, these
devices serve no
functional purpose |
4
AnyPlus Spinal Fixation System Premarket Notification: Traditional 510(k)
| | | | | and should be
removed. In most
cases, removal is
indicated because
the implants are not
intended to transfer
or support forces
developed during
normal activities.
Any decision to
remove the device
must be made by
the physician and
patient, taking into
consideration the
patient's general
medical condition
and the potential
risk to the patient for
a second surgical
procedure. |
|---------------------------|---------------------------------------------------------------------------------------------------|------------------------------------|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Titanium Alloy (Ti-
6Al-4V ELI) | Titanium Alloy (Ti-
6Al-4V ELI) | Titanium Alloy | Titanium Alloy (Ti-
6Al-4V ELI) |
| Standard of
Conformity | ASTM F1717-04,
ASTM F1798-97,
ASTM F136-98,
ISO 5832-3:1996,
ANSI/AAMI/ISO
17665-1 | | | |
.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird, with its wings spread and head turned to the right. The bird is depicted in a simple, graphic style.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
GS Medical Co., Ltd. % Oserve America, Inc. Mr. William F. Greenrose President 220 River Road Claremont, New Hampshire 03743
JAN 2 5 2010
Re: K091717
Trade/Device Name: AnyPlus Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWP, KWQ, MNH, MNI Dated: January 10, 2010 Received: January 12, 2010
Dear Mr. Greenrose:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
6
Page 2 - Mr. William F. Greenrose
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Barbara Buehrig
Mark N. Me Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K091717
Device Name:
AnyPlus Spinal Fixation System
Indications For Use:
AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation system (T1-L5), or as a anterolateral fixation system (TB-L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K091717 510(k) Number_
Page 1 of 1
Section 4.0
CONFIDENTIAL