(232 days)
Not Found
No
The device description focuses on the material composition and mechanical design of a hip prosthesis, with no mention of AI or ML capabilities. The performance studies evaluate clinical outcomes and radiographic changes, not algorithmic performance.
Yes
The device is a hip prosthesis, which is implanted to treat severe hip pain and disability caused by various conditions, indicating a therapeutic purpose.
No
Explanation: The Epoch Hip Prosthesis is a medical implant designed to replace a portion of the hip joint. Its purpose is therapeutic (to treat severe hip pain and disability) rather than diagnostic (to identify or determine the nature of a disease or condition).
No
The device description clearly states it is a femoral stem manufactured from physical materials (cobalt-chromiummolybdenum alloy, PAEK, titanium fiber metal pads) and is intended for surgical implantation. This is a hardware device, not software.
Based on the provided information, 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 Epoch Hip Prosthesis is a physical implant designed to replace a damaged or diseased hip joint. Its intended use is to alleviate pain and disability in patients with various hip conditions. It is surgically implanted into the body.
The description clearly indicates a surgical implant, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The Epoch Hip Prosthesis is indicated for:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head. and nonunion of previous fractures of the femur.
- Patients with congenital hip displasia, protrusio acetabuli, or slipped capital femoral epiphysis.
- Patients suffering from disability due to previous fusion.
- Patients with acute femoral neck fractures.
Product codes (comma separated list FDA assigned to the subject device)
LPH
Device Description
The Epoch Hip Prosthesis is a femoral stem manufactured from cobalt-chromiummolybdenum alloy, polyaryletherketone (PAEK), and commercially pure (c.p.) titanium fiber metal pads. This design is intended to permit biological fixation over the entire length of the stem.
The femoral stem is anteverted proximally and is straight distally. The device is designed to fit the proximal femur and provide an interference fit with intimate contact between the porous titanium pads and the surrounding trabecular bone. The proximal one-third is wedge-shaped with a broad medial face for optimal stress distribution. The stem is available in left and right configurations in sizes ranging from 14 to 18 mm. The design includes progressive offsets that increase in proportion with stem size for optimal restoration of joint anatomy.
The head/neck junction features a Morse-type 12/14 taper designed to mate with the corresponding 12/14 bore of a variety of femoral head components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur, hip
Indicated Patient Age Range
Not Found
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)
Clinical and radiographic performance of the Epoch Hip Prosthesis was evaluated in a six-year, multicenter clinical trial. All subjects were followed for two years and functional, radiographic and health-related quality of life evaluations were performed. Complication rates were low and comparable to literature reports for uncemented total hip arthroplasty. To date, no stems have been revised.
Functional clinical assessment by the Harris Hip Analysis indicated "excellent" outcomes for the device. Thigh pain was reduced from 78.9% of patients preoperatively, to 4.3% at 24 months.
DEXA analysis was completed on a subset of patients and suggests that periprosthetic bone loss attributable to stress shielding is less with the Epoch Hip Prosthesis than that observed in longitudinal studies of most other all-metallic femoral prostheses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Thigh pain was reduced from 78.9% of patients preoperatively, to 4.3% at 24 months.
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.
P820024, K931641, K842906, P850061, K934515
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. 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. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
K014070 p1/3
JUL 3 0 2002
Summary of Safety and Effectiveness
Submitted By: .
Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 574-267-6131
Contact Person: ●
Karen Cain Manager, Regulatory Affairs Telephone: 574/372-4219 Fax: 574/372-4605
Date: �
July 22, 2002
. Trade Name:
Epoch® Hip Prosthesis
Common Name: 0
Femoral Hip Prosthesis
Classification Name: �
Prosthesis, hip, semi-constrained, composite/polymer
Predicate Devices: .
- AML Total Hip System with Porocoat, manufactured by DePuy, P820024, . approved for use without bone cement August 19, 1983 (formerly called the Porocoat Modified Austin-Moore Total Hip Prosthesis); Porocoat Porous Coating, K931641, cleared for use without bone cement March 21, 1994
1
|C014070
- BIAS® Total Hip System, manufactured by Zimmer, K842906, cleared for use ● with bone cement August 24, 1984; P850061, approved for use without bone cement January 31, 1989, subsequently downclassified to Class II on February 21, 1992
- BIAS Fiber Metal Total Hip Stem (TFB), manufactured by Zimmer, K934515, . cleared August 24, 1995
Device Description �
The Epoch Hip Prosthesis is a femoral stem manufactured from cobalt-chromiummolybdenum alloy, polyaryletherketone (PAEK), and commercially pure (c.p.) titanium fiber metal pads. This design is intended to permit biological fixation over the entire length of the stem.
The femoral stem is anteverted proximally and is straight distally. The device is designed to fit the proximal femur and provide an interference fit with intimate contact between the porous titanium pads and the surrounding trabecular bone. The proximal one-third is wedge-shaped with a broad medial face for optimal stress distribution. The stem is available in left and right configurations in sizes ranging from 14 to 18 mm. The design includes progressive offsets that increase in proportion with stem size for optimal restoration of joint anatomy.
The head/neck junction features a Morse-type 12/14 taper designed to mate with the corresponding 12/14 bore of a variety of femoral head components.
Intended Use .
The Epoch Hip Prosthesis is indicated for:
- Patients suffering from severe hip pain and disability due to rheumatoid 1. arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head. and nonunion of previous fractures of the femur.
- Patients with congenital hip displasia, protrusio acetabuli, or slipped capital 2. femoral epiphysis.
- Patients suffering from disability due to previous fusion. 3.
- Patients with acute femoral neck fractures. 4.
2
Comparison to Predicate Devices .
All hip systems listed above are substantially equivalent to each other and the Epoch Hip Prosthesis in that each is intended for cementless fixation into the intramedullary canal for pathological or generative conditions involving the femur and/or acetabulum.
. Clinical Data
Clinical and radiographic performance of the Epoch Hip Prosthesis was evaluated in a six-year, multicenter clinical trial. All subjects were followed for two years and functional, radiographic and health-related quality of life evaluations were performed. Complication rates were low and comparable to literature reports for uncemented total hip arthroplasty. To date, no stems have been revised.
Functional clinical assessment by the Harris Hip Analysis indicated "excellent" outcomes for the device. Thigh pain was reduced from 78.9% of patients preoperatively, to 4.3% at 24 months.
DEXA analysis was completed on a subset of patients and suggests that periprosthetic bone loss attributable to stress shielding is less with the Epoch Hip Prosthesis than that observed in longitudinal studies of most other all-metallic femoral prostheses.
RA07251K.510
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three stylized human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2002
Ms. Karen Cain Manager, Regulatory Affairs Zimmer. Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K014070
Trade/Device Name: Epoch® Hip Prosthesis, Model 4075 Series Regulatory Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: May 3, 2002 Received: May 7, 2002
Dear Ms. Cain:
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 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 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.
4
· Page 2 - Ms. Karen Cain
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| Exhibit K | |
|---|---|
| ----------- | -- |
Page | of |
510(k) Number (if known_KO14070
Device Name: Epoin Hip Stuitles
Indications for Use:
The Epoch® Hip Prosthesis is indicated for:
- ﺎ . Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
-
- Patients with congenital hip displasia, protrusio acetabuli, or slipped capital femoral epiphysis.
-
- Patients suffering from disability due to previous fusion.
- Patients with acute femoral neck fractures. 4.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
RA03601K.510
Mark A. Wilkerson
vision Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number -