(163 days)
Not Found
No
The document describes a mechanical orthopedic implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the "treatment" of joint destruction, fracture, avascular necrosis, and failed previous surgeries, which are all therapeutic indications.
No
The device is an orthopedic implant (acetabular components and femoral heads) used for joint replacement, not for diagnosing medical conditions.
No
The device description clearly states it is comprised of physical components (Acetabular Components and CoCr Femoral Heads) and describes physical testing (wear, contact stress, fatigue). There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's purpose as treating joint destruction, fractures, and failed previous surgeries in the hip joint. This is a therapeutic and reconstructive purpose, not a diagnostic one.
- Device Description: The description details components of a hip replacement system (acetabular components and femoral heads). These are physical implants used in surgery.
- 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.
The device is a medical device, specifically a prosthetic implant for hip replacement surgery.
N/A
Intended Use / Indications for Use
The Inter-Op Durasul Acetabular Components and CoCr Femoral Heads are intended for use in treatment of the following:
- joint destruction resulting from degenerative, posttraumatic or Advanced 1. rheumatoid arthritis.
- Fracture or avascular necrosis of the femoral head. 2.
- Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, 3. hemiarthroplasty and total hip replacement.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI
Device Description
The Sulzer Orthopedics Inter-Op Durasul Acetabular Inserts were originally cleared via 510(k) K983509. The purpose of the present submission is to gain notice of substantial equivalence for line additions to these previously cleared insert components and corresponding metallic heads. More specifically, this includes decreased thicknesses (down to 5mm) of the previously cleared Inter-Op Durasul Standard Acetabular Insert design for use with 28, 32, 38mm and 46mm CoCr femoral heads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acetabulum (used during total hip arthroplasty)
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)
Wear, contact stress, fatigue, and locking mechanism integrity testing all indicated that these line additions would perform as intended and similar to legally marketed products. The results of in vitro wear tests have not been shown to correlate with clinical wear mechanisms
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.
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
K993259
py. #02
510(k) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for line additions to the Inter-Op™ Durasult. Acetabular components and CoCr Femoral Heads.
| Subinitter: | Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 |
|-------------------------|--------------------------------------------------------------------------------------------------------|
| Date: | September 17, 1999 |
| Contact Person: | Mitchell Dhority, RAC
Manager, Regulatory and Clinical Affairs |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous coated
uncemented prosthesis, 21 CFR 888.3358 |
| Common/Usual Name: | Total Hip Prosthesis, Semi-constrained |
| Trade/Proprietary Name: | Sulzer Orthopedics Inter-Op™ Durasul™ Acetabular Inserts and
CoCr Femoral Heads |
PRODUCT DESCRIPTION
The Sulzer Orthopedics Inter-Op Durasul Acetabular Inserts were originally cleared via 510(k) K983509. The purpose of the present submission is to gain notice of substantial equivalence for line additions to these previously cleared insert components and corresponding metallic heads. More specifically, this includes decreased thicknesses (down to 5mm) of the previously cleared Inter-Op Durasul Standard Acetabular Insert design for use with 28, 32, 38mm and 46mm CoCr femoral heads.
SPECIFIC DIAGNOSTIC INDICATIONS
Diagnostic indications for use of this device include:
- patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., theumatoid arthritis.
- those patients with failed previous surgery where pain, deformity, or dysfunction persists. t
- revision of a previously failed arthroplasty. .
SUBSTANTIAL EQUIVALENCE
The Inter-Op Durasul Standard Acetabular insert is substantially equivalent and identical in intended use, function, material and general overall design to those products cleared under K983509. These are modular components that are manufactured from the same Durasul crosslinked polyethylene, interface with the same Inter-Op Acetabular Shells and metallic heads and are used to resurface the acetabulum during total hip arthroplasty in the same indications. The main difference is the decreased polyethylene insert thickness (down to 5mm) and increase in diameter of the corresponding head sizes that will be offered.
1
K99 3254
,39 r41
Wear, contact stress, fatigue, and locking mechanism integrity testing all indicated that these line additions would perform as intended and similar to legally marketed products. The results of in vitro wear tests have not been shown to correlate with clinical wear mechanisms
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2000
Mr. Mitchell Dhority, RAC Manager, Regulatory and Clinical Affairs Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717
Re: K993259
Trade Name: Sulzer Orthopedics Inter-Op™ Durasul™ Acetabular Inserts and CoCr Femoral Heads Regulatory Class: II Product Code: LPH and JDI Dated: January 14, 2000 Received: January 18, 2000
Dear Mr. Dhority:
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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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.
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.
3
Page 2 - Mr. Mitchell Dhority, RAC
If you desire specific advice for your device on our labeling regulation (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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Kinnell Snyer
So James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| 510(k) Number (if known): | K99325-9 |
|---|---|
| --------------------------- | ---------- |
Device Name: Inter-Op Durasul Acetabular Components/CoCr Heads - Line Additions
Indications for Use:
The Inter-Op Durasul Acetabular Components and CoCr Femoral Heads are intended for use in treatment of the following:
- joint destruction resulting from degenerative, posttraumatic or Advanced 1. rheumatoid arthritis.
- Fracture or avascular necrosis of the femoral head. 2.
- Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, 3. hemiarthroplasty and total hip replacement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thamel'sayer
(Division Sign-Off) Division of General Restorative Devices
510(k) Number ________________________________________________________________________________________________________________________ 510(k) Number _
Prescription Use
OR
Over-the Counter Use
(Optional Format 1-2-96)