(90 days)
Not Found
No
The document describes a physical implant (spacer) for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is intended for use in patients with degenerative disc disease to facilitate interbody fusion, which is a therapeutic intervention.
No
The device description clearly states its purpose as an interbody fusion device, the materials it's made from, and its physical characteristics, all of which are related to therapy, not diagnosis.
No
The device description clearly states it is a physical implant manufactured from PEEK and tantalum, intended for surgical implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Falcon Spacer Function: The Falcon Spacer is a surgical implant designed to be placed between vertebrae in the spine to facilitate bone fusion. It is a physical device used within the body during a surgical procedure, not a device used to test samples outside the body.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease, not a diagnostic test.
- Device Description: The description details the materials and physical characteristics of an implantable device, not a device for analyzing biological samples.
The information provided describes a medical device used for surgical treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Falcon Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Falcon Spacer should be packed with autogenous bone graft (i.e., autograft).
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Falcon Spacer is intended to be used with supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Falcon Spacer is a radiolucent, oval-shaped spacer intended to be used as an interbody fusion device in conjunction with supplemental fixation. Pyramidal teeth that assist in further stabilization of the construct are located on the inferior and superior surfaces of the spacer. The Falcon Spacer implant may be used to accommodate varying anatomical requirements and is available in a range of heights, sizes and angles. The open architecture of the device is intended to be packed with autogenous bone (i.e., autograft).
The Falcon Spacer is manufactured from Invibio® PEEK-Optima® LT-1 (ASTM F2026) with four (4) tantalum radiopaque pins (ASTM F-560); The markers allow intra-operative radiographic assessment of the position of the implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic
Anatomical Site
L2 to S1 (Spine)
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)
Non-Clinical Performance and Conclusions:
Synthes conducted the following bench testing (as recommended by FDA Guidance and in accordance with ASTM F-2077):
Static Axial Compression Dynamic Axial Compression Static Compression Shear Subsidence Expulsion Based on information contained herein, Synthes has determined that the Falcon Spacer is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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
・
510(k) Summary 7.
JAN 0 8 2013
| 510(k) Summary – Falcon Spacer | |
|---|---|
| Name of Firm: | Synthes Spine |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Monika McDole-Russell |
| Regulatory Affairs Specialist | |
| Telephone: 610-719-5448 | |
| Facsimile: 610-719-5102 | |
| Email: mcdole-russell.monika@synthes.com | |
| Date Prepared: | December 21, 2012 |
| Trade Name(s): | Falcon Spacer |
| Classification: | 21 CFR 888.3080 – Spinal Intervertebral Body Fusion |
| Orthopaedic and Rehabilitation Devices Panel | |
| Product Code MAX Class II | |
| Predicates: | Synthes Oracle Spacer (K072791) |
| Synthes OPAL Spacer (K072791) | |
| Globus Medical PATRIOT TransContinental Spacer (K102313) | |
| Device | |
| Description(s): | The Falcon Spacer is a radiolucent, oval-shaped spacer intended to be |
| used as an interbody fusion device in conjunction with supplemental | |
| fixation. Pyramidal teeth that assist in further stabilization of the construct | |
| are located on the inferior and superior surfaces of the spacer. The Falcon | |
| Spacer implant may be used to accommodate varying anatomical | |
| requirements and is available in a range of heights, sizes and angles. The | |
| open architecture of the device is intended to be packed with autogenous | |
| bone (i.e., autograft). |
The Falcon Spacer is manufactured from Invibio® PEEK-Optima® LT-1
(ASTM F2026) with four (4) tantalum radiopaque pins (ASTM F-560);
The markers allow intra-operative radiographic assessment of the position
of the implant. |
| Intended Use/
Indications for
Use: | Falcon Spacer is indicated for use in patients with degenerative disc
disease (DDD) at one or two contiguous levels from L2 to S1 whose
condition requires the use of interbody fusion combined with
supplemental fixation. The interior of the Falcon Spacer should be
packed with autogenous bone graft (i.e., autograft).
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should |
| 510(k) Summary - Falcon Spacer | |
| | be skeletally mature and have had six months of non-operative treatment.
The Falcon Spacer is intended to be used with supplemental fixation. |
| Comparison of
the device to
predicate
device(s): | The Falcon Spacer is substantially equivalent to the predicate(s) in design,
function, performance, material, and intended use. |
| Performance
Date
(Non-Clinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
Synthes conducted the following bench testing (as recommended by FDA
Guidance and in accordance with ASTM F-2077):
Static Axial Compression Dynamic Axial Compression Static Compression Shear Subsidence Expulsion Based on information contained herein, Synthes has determined that the
Falcon Spacer is substantially equivalent to the predicate devices. |
1
:
. And the state of the same of the same
.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized symbol that resembles a person embracing or supporting another person, representing the department's mission of protecting the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: January 8, 2013
Synthes (USA) Products, LLC % Ms. Monika McDole-Russell Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K123180
Trade/Device Name: Falcon Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 21, 2012 Received: December 26, 2012
Dear Ms. McDole-Russell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Monika McDole-Russell
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement 6.
® SYNTHES®
Spine
K 123180 510(k) Number(s): (if known)
Falcon Spacer Device Name:
The Falcon Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Falcon Spacer should be packed with autogenous bone graft (i.e. autograft).
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The Falcon Spacer is intended to be used with supplemental fixation.
X Prescription Use (21 CFR 801 Subpart D) AND / OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/4/Picture/13 description: The image shows the name "Colin O'Neill" in a stylized font. The first name, "Colin," is written in a bold, sans-serif font, while the last name, "O'Neill," is also in a bold font. The letters in "O'Neill" are filled with a pattern of lines and shapes, creating a textured effect.
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123180