(86 days)
P960025
Not Found
No
The document describes a physical medical device (spinal spacers) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device, referred to as a "Spacer," is used to treat degenerative disc disease and replace diseased or damaged vertebral bodies, which are therapeutic medical conditions.
No
The device description indicates that the Synthes Oracle Spacer and OPAL Spacer are interbody fusion devices and vertebral body replacement devices, used for structural stability and to restore height. Their intended use is therapeutic (fusion, replacement), not to diagnose a condition.
No
The device description clearly describes physical implants (spacers) made of material and having specific shapes and features for surgical implantation. It does not mention any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The descriptions clearly state that the Synthes Oracle Spacer and OPAL Spacer are implants designed to be surgically placed in the spine to provide structural support and facilitate fusion. They are physical devices used within the body, not for testing samples outside the body.
The text describes a surgical implant for spinal fusion, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Synthes Oracle 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 Oracle 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 Oracle Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS (including Click'X) and small stature USS.
Synthes Oracle Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures or the treatment of tumor or trauma (i.e. fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Oracle Spacer is intended to be used with Synthes internal fixation systems, e.g., Pangea, USS (including Click'X), Small Stature USS, ATLP, TSLP, and VentroFix. The interior of the spacer can be packed with bone (autograft or allograft). The Oracle Spacer is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
The OPAL 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 OPAL 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 OPAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS (including Click'X) and small stature USS.
The OPAL Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The OPAL Spacer is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix and USS. The interior of the spacer component of the OPAL Spacer system can be packed with bone.
Product codes (comma separated list FDA assigned to the subject device)
MAX, MQP
Device Description
The Synthes Oracle Spacer is a radiolucent, oval-shaped interbody fusion device used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy. The Oracle Spacer implant may be used to accommodate the anatomical requirements of the intervertebral disc space. Pyramidal teeth that assist in further stabilization of the construct are located on the inferior and superior surfaces of the spacer. The open architecture of the device is intended to be packed with autogenous bone graft (i.e. autograft).
Synthes OPAL Spacer is a radiolucent, rectangular shaped interbody fusion device used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy. The OPAL Spacer construct is convex in shape to closely resemble patient anatomy and ensure accurate sizing. The implants have bulleted noses, and trial spacers facilitate self-distraction and insertion. The open architecture of the device is intended to be packed with autogenous bone graft (i.e. autograft).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1, thoracolumbar spine (T1-L5)
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: Based on information contained herein, Synthes has determined that the Synthes Oracle Spacer is substantially equivalent to the predicate device(s). Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Non-Clinical Performance and Conclusions: Based on information contained herein, Synthes has determined that the Synthes OPAL Spacer is substantially equivalent to the predicate device(s). Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this 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.
Depuy Acromed, Inc., Lumbar I/F Cage (P960025)
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
K072791
Page 1 of 2
DEC 2 6 2007
510(k) Summary – Oracle Spacer
| 510(k) Summary - Oracle Spacer | |
|---|---|
| Name of Firm: | Synthes Spine |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Stacey Bonnell |
| Associate Regulatory Affairs Specialist | |
| Telephone: 610-719-5895 | |
| Facsimile: 610-719-5102 | |
| Email: bonnell.stacey@synthes.com | |
| Date Prepared: | December 21, 2007 |
| Trade Name(s): | Synthes Oracle Spacer |
| Classification: | 21 CFR 888.3080 - Spinal Intervertebral Body Fusion |
| Orthopaedic and Rehabilitation Devices Panel | |
| Product Code MAX | |
| Class II | |
| 21 CFR 888.3060 - Spinal Vertebral Body Replacement Device | |
| Orthopaedic and Rehabilitation Devices Panel | |
| Product Code MQP | |
| Class II | |
| Predicates: | Depuy Acromed, Inc., Lumbar I/F Cage (P960025) |
| Device | |
| Description(s): | The Synthes Oracle Spacer is a radiolucent, oval-shaped interbody |
| fusion device used in conjunction with supplemental fixation to provide | |
| structural stability in skeletally mature individuals following total or | |
| partial discectomy. The Oracle Spacer implant may be used to | |
| accommodate the anatomical requirements of the intervertebral disc | |
| space. Pyramidal teeth that assist in further stabilization of the construct | |
| are located on the inferior and superior surfaces of the spacer. The open | |
| architecture of the device is intended to be packed with autogenous bone | |
| graft (i.e. autograft). | |
| 510(k) Summary - Oracle Spacer | |
| Intended Use/ | |
| Indications for | |
| Use: | Synthes Oracle 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 Oracle 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 Oracle Spacer is | |
| intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, | |
| Antegra, Pangea, USS (including Click'X) and small stature USS. | |
| Synthes Oracle Spacer is a vertebral body replacement device intended | |
| for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral | |
| body resected or excised during partial and total vertebrectomy | |
| procedures or the treatment of tumor or trauma (i.e. fracture), to achieve | |
| anterior decompression of the spinal cord and neural tissues, and to | |
| restore the height of the collapsed vertebral body. The Oracle Spacer is | |
| intended to be used with Synthes internal fixation systems, e.g., Pangea, | |
| USS (including Click'X), Small Stature USS, ATLP, TSLP, and | |
| VentroFix. The interior of the spacer can be packed with bone (autograft | |
| or allograft). The Oracle Spacer is designed to restore the biomechanical | |
| integrity of the anterior, middle, and posterior spinal column even in the | |
| absence of fusion for a prolonged period. | |
| Comparison of | |
| the device to | |
| predicate | |
| device(s): | Synthes Oracle Spacer is substantially equivalent to the predicate(s) in |
| design, function, performance, and material. Synthes Oracle Spacer is | |
| similar to Depuy AcroMed's Lumbar I/F Cage (P960025) with regards to | |
| Indications for Use. | |
| Performance | |
| Date | |
| (Non-Clinical | |
| and/or Clinical): | Non-Clinical Performance and Conclusions: |
| Based on information contained herein, Synthes has determined that the | |
| Synthes Oracle Spacer is substantially equivalent to the predicate | |
| device(s). | |
| Clinical Performance and Conclusions: | |
| Clinical data and conclusions were not needed for this device. |
1
2
K072791 Page 1 of 2
510(k) Summary -- OPAL Spacer
| 510(k) Summary - OPAL Spacer - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - | |
|---|---|
| Name of Firm: | Synthes Spine |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Stacey Bonnell |
| Associate Regulatory Affairs Specialist | |
| Telephone: 610-719-5895 | |
| Facsimile: 610-719-5102 | |
| Email: bonnell.stacey@synthes.com | |
| Date Prepared: | December 21, 2007 |
| Trade Name(s): | Synthes OPAL Spacer |
| Classification: | 21 CFR 888.3080 - Spinal Intervertebral Body Fusion |
| Orthopaedic and Rehabilitation Devices Panel | |
| Product Code MAX | |
| Class II | |
| 21 CFR 888.3060 - Spinal Vertebral Body Replacement Device | |
| Orthopaedic and Rehabilitation Devices Panel | |
| Product Code MQP | |
| Class II | |
| Predicates: | Depuy Acromed, Inc., Lumbar I/F Cage (P960025) |
| Device | |
| Description(s): | Synthes OPAL Spacer is a radiolucent, rectangular shaped interbody |
| fusion device used in conjunction with supplemental fixation to provide | |
| structural stability in skeletally mature individuals following total or | |
| partial discectomy. The OPAL Spacer construct is convex in shape to | |
| closely resemble patient anatomy and ensure accurate sizing. The | |
| implants have bulleted noses, and trial spacers facilitate self-distraction | |
| and insertion. The open architecture of the device is intended to be packed | |
| with autogenous bone graft (i.e. autograft). | |
| 510(k) Summary - OPAL Spacer | |
| Intended Use/ | |
| Indications for | |
| Use: | Synthes OPAL 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 OPAL 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 OPAL Spacer is | |
| intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, | |
| Antegra, Pangea, USS (including Click'X) and small stature USS. | |
| Synthes OPAL Spacer is a vertebral body replacement device intended | |
| for use in the thoracolumbar spine (T1-L5) to replace a collapsed, | |
| damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). | |
| The OPAL Spacer is intended to be used with Synthes supplemental | |
| internal fixation systems, e.g., ATLP, VentroFix and USS. The interior of | |
| the spacer component of the OPAL Spacer system can be packed with | |
| bone. | |
| Comparison of | |
| the device to | |
| predicate | |
| device(s): | Synthes OPAL Spacer is substantially equivalent to the predicate(s) in design, |
| function, performance, and material. Synthes OPAL Spacer is similar to Depuy | |
| AcroMed's Lumbar I/F Cage (P960025) with regards to Indications for Use. | |
| Performance | |
| Date | |
| (Non-Clinical | |
| and/or Clinical): | Non-Clinical Performance and Conclusions: |
| Based on information contained herein, Synthes has determined that the Synthes | |
| OPAL Spacer is substantially equivalent to the predicate device(s). | |
| Clinical Performance and Conclusions: | |
| Clinical data and conclusions were not needed for this device. |
3
KO72791
Page 2 of 2
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and three human figures in silhouette are visible within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes Spine % Ms. Stacey Bonnell Associate Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
MAY 1 7 2012
Re: K072791
Trade/Device Name: Synthes Oracle and OPAL Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: September 28, 2007 Received: October 1, 2007
Dear Ms. Bonnell:
This letter corrects our substantially equivalent letter of December 26, 2007.
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 (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
5
Page 2 - Ms. Stacey Bonnell
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 (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 yours,
Mark A. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Image /page/6/Picture/0 description: The image shows the logo for Synthes Spine. The logo consists of the Synthes symbol, followed by the word "SYNTHES" in bold, sans-serif font. Below the word "SYNTHES" is the word "Spine" in a smaller, sans-serif font.
Indications for Use Statement - Synthes Oracle Spacer
K072791 510(k) Number:
Synthes Oracle Spacer Device Name:
Indications for Use:
Synthes Oracle Spacer is indicated for use in patients with degenerative disc disease Synnies Oracic Spacer 16 marcated 103 from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Oracle Spacer should be packed with autogenous bone graft (i.e. autograft).
Should be packed with advigences oone good go origin with degeneration of the disc confimed DDD is delined as back pain of also gations should be skeletally mature and have had six months of non-operative treatment.
*The Oracle Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS (including Click'X) and small stature USS.
Synthes Oracle Spacer is a vertebral body replacement device intended for use in the Synthes Oracic Opacor is a verteoral coa diseased vertebral body resected or excised thoracountion spine (11 25) to reply procedures for the treatment of tumor or trauma during partial and total verseresting procession of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Oracle Spacer is intended to be to restore the neight of the occraped systems, e.g., Pangea, USS (including Click'X), Small used with bynthes michial interior systems, The interior of the spacer can be packed with bone (autograft or allograft).
The Oracle Spacer is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
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) | |
|---|---|
| 115 |
(Diffsion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
长072791 510(k) Number_
7
Indications for Use Statement - OPAL Spacer
9 3 1111 12 3 Spine
K072791 510(k) Number(s): (if known)
Device Name: Synthes OPAL Spacer
The OPAL 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 OPAL 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 OPAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS (including Click'X) and small stature USS.
The OPAL Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The OPAL Spacer is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix and USS. The interior of the spacer component of the OPAL Spacer system can be packed with bone.
Prescription Use X (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, (Division Sign-Off)
Division of General. Restorative. and Neurological Devices
510(k) Number K072791 p. 2/2