(71 days)
Not Found
Not Found
No
The description focuses on the mechanical design and materials of the acetabular components and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an acetabular component system used for total hip replacement, which is a medical procedure to alleviate pain and improve joint function in patients with disabling hip joint diseases. This aligns with the definition of a therapeutic device designed to treat a medical condition.
No
Explanation: The device is an acetabular component system used for hip replacement surgery. Its purpose is to treat painful and disabling joint diseases by replacing a damaged hip joint, not to diagnose a condition.
No
The device description clearly details physical components (shells, inserts) made of metal and other materials, intended for surgical implantation. This is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text describes a hip implant system (acetabular components) used for surgical replacement of the hip joint. This is a surgical device implanted directly into the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes related to analyzing bodily fluids or tissues.
Therefore, based on the provided information, the Osteonics® Secur-Fit™-AD Generation II Acetabular Components are a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Osteonics® Secur-Fit™-AD Generation II Acetabular Components are single-use devices. The shells are intended for cemented or cementless fixation within the prepared acetabulum. The Osteonics® Secur-Fit™-AD Generation II Acetabular Component System is compatible with any appropriately selected Osteonics hip stem/femoral head combination.
Indications:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous failed femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Product codes
LPH
Device Description
The Osteonics® Secur-Fit™-AD Generation II Acetabular Component System consists of single-use devices. Each Osteonics® Secur-Fit™-AD Generation II Acetabular Component consists of two pieces: an Osteonics® Secur-Fit™-AD Generation II Acetabular Shell and an Osteonics® Generation II Cup Insert. The metal shell is intended for cementless fixation within the prepared acetabulum.
The Osteonics® Secur-Fit™-AD Generation II Acetabular Shells are characterized by the following features:
- A basic dual radius design.
- The predicate interior geometry which allows a mating polyethylene insert size to be used with more than one shell size.
- A variety of screw hole patterns, including dome hole and peripheral screw holes.
- A dome hole which is compatible with the optional, currently marketed Osteonics® Acetabular Dome Hole Plugs.
- Circumferential normalizations.
- A wide range of sizes.
- Osteonics' AD coating.
- Compatibility with the Generation II Cup Insert.
The Osteonics® Generation II Cup Inserts are characterized by the following features:
- A wireless locking mechanism which utilizes a continuous ridge which locks into a groove on the interior of the mating shell.
- A hemispherical geometry which is designed to maximize liner conformity to mating shell.
- Increased indexability through mating of barbs on shell with scalloped areas on insert.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, acetabulum
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)
Performance Data:
The performance characteristics of the "AD" coatings have been presented in predicate 510(k) submissions. Mechanical testing of the subject shell/insert locking mechanism and fatigue performance is provided in this submission and demonstrate substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Osteonics® Secur-Fit™-AD Acetabular Components, Osteonics® Modular Acetabular Cup System, Osteonics® Omnifit® Series II Cup Inserts
Reference Device(s)
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
DEC 1 6 1998
Osteonics® Secur-Fit™-AD Generation II Acetabular Component System
510(k) Summary
510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® Secur-Fit™-AD Generation II Acetabular Component System
Submission Information
Name and Address of the Sponsor Osteonics Corporation of the 510(k) Submission: 59 Route 17 Allendale, NJ 07401-1677 Marybeth Naughton Contact Person: Regulatory Affairs Team Member
Date of Summary Preparation:
Device Identification
Proprietary Name:
Common Name:
Classification Name and Reference:
Osteonics® Secur-Fit™-AD Generation II Acetabular Component System
October 5, 1998
Artificial Acetabular Component
Hip Joint Metal/Polymer/Metal, Semi-Constrained Porous Coated, Uncemented Prosthesis 21 CFR §888.3358
Predicate Device Identification
The Osteonics® Secur-Fit™-AD Generation II Acetabular Component System is substantially equivalent to the Osteonics devices, which have previously been determined substantially equivalent by FDA:
- Osteonics® Secur-Fit™-AD Acetabular Components .
- Osteonics® Modular Acetabular Cup System. .
- Osteonics® Omnifit® Series II Cup Inserts. .
1
Device Description
The Osteonics® Secur-Fit™-AD Generation II Acetabular Component System consists of single-use devices. Each Osteonics® Secur-Fit™-AD Generation II Acetabular Component consists of two pieces: an Osteonics® Secur-Fit™-AD Generation II Acetabular Shell and an Osteonics® Generation II Cup Insert. The metal shell is intended for cementless fixation within the prepared acetabulum.
The Osteonics® Secur-Fit™-AD Generation II Acetabular Shells are characterized by the following features:
- . A basic dual radius design.
- . The predicate interior geometry which allows a mating polyethylene insert size to be used with more than one shell size.
- . A variety of screw hole patterns, including dome hole and peripheral screw holes.
- A dome hole which is compatible with the optional, currently marketed Osteonics® Acetabular Dome Hole Plugs.
- Circumferential normalizations.
- A wide range of sizes.
- Osteonics' AD coating.
- Compatibility with the Generation II Cup Insert.
The Osteonics® Generation II Cup Inserts are characterized by the following features:
- � A wireless locking mechanism which utilizes a continuous ridge which locks into a groove on the interior of the mating shell.
- � A hemispherical geometry which is designed to maximize liner conformity to mating shell.
- � Increased indexability through mating of barbs on shell with scalloped areas on insert.
Intended Use:
The Osteonics® Secur-Fit™-AD Generation II Acetabular Components are single-use devices. The shells are intended for cemented or cementless fixation within the prepared acetabulum. The Osteonics® Secur-Fit™-AD Generation II Acetabular Component System is compatible with any appropriately selected Osteonics hip stem/femoral head combination.
Indications:
The indications for the use of the Osteonics® Secur-Fit™-AD Generation II Acetabular Components, in keeping with those of other legally marketed Osteonics acetabular components, are as follows:
- · Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- . Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
2
- · Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum.
Statement of Technological Comparison:
The substantial equivalence of the Osteonics® Secur-Fit™-AD Generation II Acetabular Components to the predicate devices identified above-in terms of intended use, materials, and design features-is based on the following.
Intended Uses:
The Osteonics® Secur-Fit™-AD Generation II Acetabular Components, like the predicate acetabular components cited above, are intended for cementless fixation. The subject devices and the predicate devices share the same indications for use.
Materials:
The Osteonics® Secur-Fit™-AD Generation II Acetabular Shells are fabricated from ASTM F-620 Titanium Ti6Al-4V ELI Alloy which is different from the predicate acetabular shells cited above which are fabricated from ASTM F-67 CP Titanium, but identical to other Osteonics' products, such as the Osteonics Titanium Femoral Stems, which have a long history of biocompatibility and clinical performance. The Osteonics® Secur-Fit™ -AD Generation II Acetabular Shells feature Osteonics' AD coating (arc-deposited CP Ti) as do predicate Osteonics® Secur-Fit™-AD Acetabular Shells and Osteonics® Modular Acetabular Cup System.
'The Osteonics® Generation II Cup Inserts and the predicate Osteonics® Omnifit® Series II Cup Inserts are both manufactured from ultra-high molecular weight polyethylene.
Design:
The Osteonics® Secur-Fit™-AD Generation II Acetabular Shells maintain design features consistent with the predicate Osteonics® Acetabular Components as follows:
- · A basic dual radius design.
- A variety of screw hole patterns, including dome screw holes and peripheral screw holes. .
- A dome hole which is compatible with the optional, currently marketed Osteonics® ● Acetabular Dome Hole Plug.
- Circumferential normalizations. .
- A wide range of sizes. .
- Osteonics AD coating.
- A locking mechanism which maintains or exceeds the strength characteristics of predicate . devices.
3
The Osteonics® Generation II Cup Inserts are characterized by the following design features which are consistent with predicate inserts:
- · Availability in 22mm, 26mm, and 32mm inner diameter with the same minimum polyethylene thickness.
- . Availability in 0 degree and 10 degree insert versions.
- . Availability with 2mm offset and 6mm (eccentric) offset configurations.
- . A comparable rotating locking mechanism to predicate devices which utilizes the mating of barbs on the shell to scalloped areas on the insert.
- . Indexability of insert within the shell to provide ease of alignment of mating insert/shell.
Summary
Based on the similarities presented above, the supporting testing reproduced in Appendix C, and the fact that the Osteonics® Secur-Fit™-AD Generation II Acetabular Component System employs standard sterilization and packaging methods, the substantial equivalence of the Osteonics® Secur-Fit™-AD Generation II Acetabular Component System to other legally marketed, class II, acetabular components is demonstrated.
Performance Data:
The performance characteristics of the "AD" coatings have been presented in predicate 510(k) submissions. Mechanical testing of the subject shell/insert locking mechanism and fatigue performance is provided in this submission and demonstrate substantial equivalence to the predicate devices.
4
Image /page/4/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
DEC I 6 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marybeth Naughton Requlatory Affairs Team Member Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey
K983502 Re : Osteonics® Secur-Fit™-AD Generation II Trade Name: Acetabular Component System Regulatory Class: II Product Code: LPH Dated: October 5, 1998 Received: October 6, 1998
Dear Ms. Naughton:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Marybeth Naughton
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Colia M. Witton, Ph.D., M
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
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Page 1 of 1
510(k) Number (if Known): K983502_____________________________________________________________________________________________________________________________________________
Device Name: Osteonics® Secur-Fit™-AD Generation II Acetabular Component System
Indications For Use:
The Osteonics® Secur-Fit™-AD Generation II Acetabular Components are single-use devices. The shells are intended for cemented or cementless fixation within the prepared acetabulum. The Osteonics® Secur-Fit™-AD Generation II Acetabular Component System is compatible with any appropriately selected Osteonics hip stem/femoral head combination.
Indications:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, ● rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous failed femoral head replacement, cup arthroplasty or other ● procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques . are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques ● as indicated by deficiencies of the acetabulum.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
podee
Prescription Use X
OROver-The-Counter Use (per21CFR 801.109(Optional Format 1-2-96)