(77 days)
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No
The document describes a mechanical shoulder prosthesis system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a prosthesis intended for reconstruction or replacement of the shoulder joint to alleviate pain and restore function caused by various pathologies, which falls under the definition of a therapeutic device designed to treat a medical condition.
No
The device description clearly states it is a "partial or total replacement of the shoulder joint," indicating it is a prosthetic implant for treatment, not for diagnosing conditions.
No
The device description clearly states it consists of metallic stems, humeral heads, an eccenter offset adjustment mechanism, and UHMWPE glenoid components, which are all physical hardware components.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a surgical implant intended for the replacement of a shoulder joint. It is a physical device implanted into the body to restore function and alleviate pain.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
The Synthes Epoca Shoulder Prosthesis System is a medical device, specifically a prosthetic implant, used in a surgical procedure.
N/A
Intended Use / Indications for Use
The Synthes Epoca Shoulder Prosthesis System is intended for use as a hemi or total shoulder replacement. It is a single use device for reconstruction of the glenohumeral joint in the presence of complex fractures (i.e., 3 and 4 part), revision of failed fixation or arthroplasty, post-traumatic mal-union and disabled, painful shoulder joints resulting from various forms of arthropathy such as osteoarthritis, rheumatoid arthritis, traumatic arthritis or avascular necrosis and other pathologies where arthrodesis is not acceptable. The Press-fit Titanium Plasma Sprayed Humeral Stems are for cementless use only.
Product codes
MBF, HSD, KWT
Device Description
The Synthes Epoca Shoulder Prosthesis System is intended for partial or total replacement of the shoulder joint. The Synthes Epoca Shoulder Prosthesis System consists of metallic cemented and uncemented fixation stems (available with HA coating), humeral heads, an eccenter offset adjustment mechanism, and UHMWPE glenoid components. The components are available in a variety of sizes for primary and revision applications. The components are manufactured from CoCrMo Alloy, Titanium, and Ultra-High Molecular Weight Polyethylene (UHMWPE).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Shoulder joint
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Synthes Epoca Shoulder Prosthesis System, Howmedica Osteonics Solar PureFix HA Shoulder
Reference Device(s)
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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).
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§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”
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A SYNTHES®
FEB = 5 2009
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| ----- | ---------------- | ------------- |
| Sponsor: | Synthes
1301 Goshen Parkway
West Chester, PA 19380
(610) 719-6604 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Amnon Talmor
Synthes
1301 Goshen Parkway
West Chester, PA 19380
(610) 719-6604 |
| Device Name: | Synthes Epoca Shoulder Prosthesis System, HA Coated Stems |
| Classification: | Class II, §888.3670 - Shoulder joint metal/polymer metal
nonconstrained or semi-constrained porous-coated uncemented
prosthesis
Class II, §888.3690 - Shoulder joint humeral (hemi-shoulder)
metallic uncemented prosthesis |
| Predicate Devices: | Synthes Epoca Shoulder Prosthesis System
Howmedica Osteonics Solar PureFix HA Shoulder |
| Device Description: | The Synthes Epoca Shoulder Prosthesis System is intended for
partial or total replacement of the shoulder joint. The Synthes
Epoca Shoulder Prosthesis System consists of metallic cemented
and uncemented fixation stems (available with HA coating),
humeral heads, an eccenter offset adjustment mechanism, and
UHMWPE glenoid components. The components are available in
a variety of sizes for primary and revision applications. The
components are manufactured from CoCrMo Alloy, Titanium, and
Ultra-High Molecular Weight Polyethylene (UHMWPE). |
| Intended Use: | The Synthes Epoca Shoulder Prosthesis System is intended for
use as a hemi or total shoulder replacement. It is a single use
device for reconstruction of the glenohumeral joint in the presence
of complex fractures (i.e., 3 and 4 part), revision of failed fixation
or arthroplasty, post-traumatic mal-union and disabled, painful
shoulder joints resulting from various forms of arthropathy such as
osteoarthritis, rheumatoid arthritis, traumatic arthritis or avascular
necrosis and other pathologies where arthrodesis is not
acceptable. The Press-fit Titanium Plasma Sprayed Humeral
Stems are for cementless use only. |
| Substantial Equivalence: | The information presented supports substantial equivalence. |
:
:
. . .
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 5 2009
Synthes (USA) % Mr. Amnon Talmor Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K083439
Trade/Device Name: Synthes Epoca Shoulder Prosthesis System Regulation Number: 21 CFR 888.3670
Regulation Name: Shoulder joint metal/polymer/metal nonconstrained or semiconstrained porous-coated uncemented prosthesis.
Regulatory Class: II Product Code: MBF, HSD, KWT Dated: November 19, 2008 Received: November 24, 2008
Dear Mr. Talmor:
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. Iisting 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 such 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); good manufacturing practice requirements as set
2
Page 2 - Mr. Amnon Talmor
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)); please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N Mulhausen
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
2.0
Indications for Use
510(k) Number (if known):
Device Name:
Synthes Epoca Shoulder Prosthesis System
Indications for Use:
The Synthes Epoca Shoulder Prosthesis System is intended for use as a hemi or total shoulder replacement. It is a single use device for reconstruction of the glenohumeral joint in the presence of complex fractures (i.e., 3 and 4 part), revision of failed fixation or arthroplasty, post-traumatic mal-union and disabled, painful shoulder joints resulting from various forms of arthropathy such as osteoarthritis, rheumatoid arthritis, traumatic arthritis or avascular necrosis and other pathologies where arthrodesis is not acceptable. The Press-fit Titanium Plasma Sprayed Humeral Stems are for cementless use only.
Prescription Use (Per 21 CFR 801.109) 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)
(Division 200-2017 Division of General, Restorative, and Neurological Devices
510(k) Number