(49 days)
Not Found
No
The device description focuses on the materials, design, and mechanical features of an acetabular shell system for hip replacement. There is no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a medical implant (acetabular shell) used in total hip arthroplasty to reduce pain and improve hip function, falling under the definition of a therapeutic device designed to treat a medical condition.
No
Explanation: This document describes an acetabular shell system used for total hip arthroplasty, which is a surgical implant. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines a physical implantable device made of titanium alloy with porous coating, designed for total hip arthroplasty. It is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical implantation in the human body to replace the acetabular surface during total hip arthroplasty. This is a therapeutic and structural intervention, not a diagnostic test performed in vitro (outside the body) on biological specimens.
- Device Description: The device is a physical implant made of titanium alloy and coated with titanium beads. It is designed for mechanical fixation within the hip joint. This is consistent with a surgical implant, not a diagnostic reagent or instrument used for analyzing samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. .
- Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. .
- . Proximal femoral fractures
- . Avascular necrosis of the femoral head
- . Non-union of proximal femoral neck fractures
- Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa ● vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomaliacia, osteoporosis, pseudarthrosis conversion and structural abnormalities.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO
Device Description
The Consensus Acetabular Shell System consists of four modular shell options which mate with currently marketed polyethelyne insert components for replacement of the acetabular surface during total hip arthroplasty. The shells are designed to be implanted without bone cement. Cementless (press-fit) fixation is achieved by coating the external surface of the cup with commercially pure (CP) titanium sintered beads.
All of the shell options have the following common features:
-
The substrate material of the Consensus Shells is titanium alloy (ASTM F136, Ti-6AI-4V) ●
-
· The shell is porous coated with commercially pure (CP) titanium sintered beads (ASTM F67, irregular bead geometry).
-
· The shells have the same internal locking mechanism as the previously cleared Consensus Acetabular Shells (K922561).
-
· The apical dome hole of the shells is threaded to accept an impaction tool for implanting the component. After implantation and the impaction tool is removed, a threaded titanium (ASTM F67 or F136) hole plug can be inserted into the threaded hole to prevent migration of unwanted particles through the dome hole.
The following shell options are available:
- · Total Hemispherical in no screw holes or three (3) quadrant screw holes options.
- · Hemispherical with rim flare in no screw holes or three (3) quadrant screw holes options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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.
K922561, K002149, K031110, K022711, K974095
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
Page 1 of 2
Section 9 510(k) Summary of Safety and Effectiveness
Defined in 21 CFR 807 In accordance with 21 CFR 807.92 (Summary)
Fir 28 2003
| Applicant's Name: | Hayes Medical, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills, CA 95682 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Luke Rose |
| Trade Name: | Consensus Acetabular Shell System |
| Common Name: | Acetabular Shell, porous, uncemented |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coated
uncemented prosthesis (21 CFR 888.3358, Product Code LPH) |
| | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis (21 CFR 888.3353, Product
Code LZO) |
| Proposed Regulatory Class: | Class II |
| Device Classification Panel: | Orthopaedic |
| Substantially Equivalent To: | Hayes Medical, Consensus Acetabular Shell (K922561)
Wright Medical, Lineage Cup (K002149)
Apex Surgical, Modular Acetabular Cup (K031110)
Orthopaedic Source, Avalon Acetabular Cup (K022711)
Encore, Foundation Porous Acetabular System (K974095) |
Intended Use:
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. .
- Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. .
- . Proximal femoral fractures
- . Avascular necrosis of the femoral head
- . Non-union of proximal femoral neck fractures
- Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa ● vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomaliacia, osteoporosis, pseudarthrosis conversion and structural abnormalities.
Device Description:
The Consensus Acetabular Shell System consists of four modular shell options which mate with currently marketed polyethelyne insert components for replacement of the acetabular surface during total hip arthroplasty. The shells are designed to be implanted without bone cement. Cementless (press-fit) fixation is achieved by coating the external surface of the cup with commercially pure (CP) titanium sintered beads.
All of the shell options have the following common features:
- The substrate material of the Consensus Shells is titanium alloy (ASTM F136, Ti-6AI-4V) ●
1
Page 2 of 2
- · The shell is porous coated with commercially pure (CP) titanium sintered beads (ASTM F67, irregular bead geometry).
- · The shells have the same internal locking mechanism as the previously cleared Consensus Acetabular Shells (K922561).
- · The apical dome hole of the shells is threaded to accept an impaction tool for implanting the component. After implantation and the impaction tool is removed, a threaded titanium (ASTM F67 or F136) hole plug can be inserted into the threaded hole to prevent migration of unwanted particles through the dome hole.
The following shell options are available:
- · Total Hemispherical in no screw holes or three (3) quadrant screw holes options.
- · Hemispherical with rim flare in no screw holes or three (3) quadrant screw holes options.
Comparison to Cleared Device
The following changes have been made to the previously cleared Consensus Acetabular Shell (K922561):
- Addition of the Hemisphical with rim flare outer profile .
- Removal of the two inferior screw holes. Holed cups now have three instead of five screw holes. .
- The apical dome hole has been threaded. .
- . A threaded apical dome hole plug is now available.
- . The porous coating is being modified from a spherical sintered CP titanium bead to an irregular sintered CP titanium bead.
The locking mechanism between the polyethylene (UHMWPE) liner and the acetabular shell is identical to the previously cleared Consensus Acetabular Shell (K922561). The safety and effectiveness of this locking detail is described in testing contained within the original submission.
Substantial Equivalence Information
The intended use, material, design features and type of interface of the Consensus Acetabular Shell System are substantially equivalent to competitive devices previously cleared for market. The safety and effectiveness of the Consensus Acetabular Shell System are adequately supported by the substantial equivalence information and materials data provided within this Special 510(k) submission.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the top half of the circle. Inside the circle is an abstract image of a bird-like figure with three wing-like shapes above a wavy line.
APR 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hayes Medical, Inc. c/o Mr. Luke Rose Director, Quality Systems and Regulatory Affairs 1115 Windfield Way - Suite 100 El Dorado Hills, California 95762
Re: K060635
Trade/Device Name: Consensus Total Hip System, Acetabular Cup Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Codes: LPH and LZO Dated: March 30, 2006 Received: March 31, 2006
Dear Mr. Rose:
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. În 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
3
Page 2 - Mr. Luke Rose
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hicker Lerner (o)
Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Consensus Acetabular Cup System Device Name:
Indications For Use:
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
- B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
- C. Proximal femoral fractures
- D. Avascular necrosis of the femoral head
- E. Non-union of proximal femoral neck fractures
- F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion and structural abnormalities.
Prescription Use __ X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
f CERTAIN STATES OF AMERICA
Division of General. Restorative. and Neurological Devices
| Onno
| at | of | |
|---|---|---|
| 4 | -4-4-46-4 |
510(k) Number K060635