(593 days)
McKee-Farrar Total Hip 1, Ring Total Hip L, Sivash Total Hip
Not Found
No
The description focuses on the materials, dimensions, and mechanical design of the hip replacement components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "inter-Op Metasul Acetabular System" and is "intended for use in cases of total hip replacement" to treat conditions like "non-inflammatory degenerative joint disease" and "inflammatory degenerative joint disease," which are therapeutic interventions.
No
The device description and intended use clearly indicate that it is an acetabular system and femoral head used for total hip replacement, which is a therapeutic intervention, not a diagnostic process.
No
The device description clearly outlines physical components made of materials like polyethylene and metal, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Inter-Op Metasul Acetabular System is a surgical implant designed to replace components of the hip joint. It is a physical device implanted into the body.
- Intended Use: The intended use is for total hip replacement surgery to treat conditions affecting the hip joint. This is a surgical procedure, not a diagnostic test performed on a specimen.
The description clearly indicates a medical device intended for surgical implantation, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Inter-Op Metasul Acetabular System is intended for use in cases of total hip replacement for treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 1. osteoarthritis, post traumatic arthritis or avascular necrosis and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity or dysfunction persists. 2.
- Revision of previously failed hip arthroplasty. 3.
Product codes (comma separated list FDA assigned to the subject device)
KWA
Device Description
The Inter-On Acetabular System is comprised of two components: (1) a polyethylene acetabular insert with an integral Metal inlay (inner diameter), and (2) a Metasul femoral head.
Inter-Op Metasul Acetabular Insert
The Inter-On Metasul Acetabular Insert is a hemispherical polyethylene component manufactured from UHMWPE (ASTM F648). The outer diameter of the insert is machined with locking features that mate with one of the previously cleared Inter-Op metallic acetabular shells.
The inner diameter which forms the bearing surface of the insert features a metallic Metasul inlay that is integrally locked to the polyethylene insert. The metal inlay is manufactured from Protasul -21WF, a wrought forged CoCrMo alloy (ISO 5832). This inlay is polished to a mirrorfinish and hot-pressed into the UHMWPE backing. Just prior to hot-pressing, two Protasul-10 (CoCr alloy, ASTM F562) pins are press fit into the design of the inlay to help provide added rotational stability. The Metasul inlay is designed for use only with the Metasul head component.
The Inter-Op Metasul Acetabular Insert component is available with outside diameters of 49mm to 81mm (in 2mm increments) with an inner diameter of 28mm.
Metasul Femoral Head
The Metasul Femoral Heads are manufactured from the same Protasul-21WF (CoCr, ISO 5832) material as the metal inlay of the acetabular component. The design incorporates a 12/14 morse type female taper with beveled face for ease of reduction intraoperatively. The female taper matches the 12/14 male taper used on Sulzer Orthopedics femoral stems.
The Metasul femoral heads are designed specifically to articulate with the Metasul inlay of the High precision manufacturing allows for optimal articulating surface acetabular component. geometry (e.g., clearance between the Metasul head and the Metasul inlay). These devices are manufactured within tight tolerances because the success of the system is dependent on optimal performance at this articulating interface
The Metasul heads are available in 28mm diameter with four neck lengths: short (-4mm), medium (neutral), long (+4mm) and extra long (+8mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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)
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.
McKee-Farrar Total Hip 1, Ring Total Hip L, Sivash Total Hip
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
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
K9 74728
510(k) SUMMARY
In accordance with the Food and Drug Administration Interim 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 510(k) summary for the Sulzer Orthopedics Inc. Inter-Op Metasul Acetabular System.
| Submitter: | Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, TX 78717
(512)432-9900 |
|-------------------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs |
| Classification Name: | CFR 888.3330 - Hip joint metal/metal semiconstrained, with an
uncemented acetabular component, prosthesis |
| Common/Usual Name: | Acetabular insert and head component of a total hip replacement |
| Trade/Proprietary Name: | Inter-Op Metasul Acetabular System |
PRODUCT DESCRIPTION:
The Inter-On Acetabular System is comprised of two components: (1) a polyethylene acetabular insert with an integral Metal inlay (inner diameter), and (2) a Metasul femoral head.
Inter-Op Metasul Acetabular Insert
The Inter-On Metasul Acetabular Insert is a hemispherical polyethylene component manufactured from UHMWPE (ASTM F648). The outer diameter of the insert is machined with locking features that mate with one of the previously cleared Inter-Op metallic acetabular shells.
The inner diameter which forms the bearing surface of the insert features a metallic Metasul inlay that is integrally locked to the polyethylene insert. The metal inlay is manufactured from Protasul -21WF, a wrought forged CoCrMo alloy (ISO 5832). This inlay is polished to a mirrorfinish and hot-pressed into the UHMWPE backing. Just prior to hot-pressing, two Protasul-10 (CoCr alloy, ASTM F562) pins are press fit into the design of the inlay to help provide added rotational stability. The Metasul inlay is designed for use only with the Metasul head component.
The Inter-Op Metasul Acetabular Insert component is available with outside diameters of 49mm to 81mm (in 2mm increments) with an inner diameter of 28mm.
Metasul Femoral Head
The Metasul Femoral Heads are manufactured from the same Protasul-21WF (CoCr, ISO 5832) material as the metal inlay of the acetabular component. The design incorporates a 12/14 morse type female taper with beveled face for ease of reduction intraoperatively. The female taper matches the 12/14 male taper used on Sulzer Orthopedics femoral stems.
The Metasul femoral heads are designed specifically to articulate with the Metasul inlay of the High precision manufacturing allows for optimal articulating surface acetabular component.
1
geometry (e.g., clearance between the Metasul head and the Metasul inlay). These devices are manufactured within tight tolerances because the success of the system is dependent on optimal performance at this articulating interface
The Metasul heads are available in 28mm diameter with four neck lengths: short (-4mm), medium (neutral), long (+4mm) and extra long (+8mm).
SPECIFIC DIAGNOSTIC INDICATIONS:
The Inter-Op Metasul Acetabular System is intended for use in cases of total hip replacement for treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 1. osteoarthritis, post traumatic arthritis or avascular necrosis and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity or dysfunction persists. 2.
- Revision of previously failed hip arthroplasty. 3.
SUBSTANTIAL EQUIVALENCE:
Substantial equivalence determination is based on comparison of the Inter-Op Metasul Acetabular System to the following preamendments predicate devices:
- McKee-Farrar Total Hip 1
- Ring Total Hip L
- Sivash Total Hip
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 eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG = 3 1999
Mitchell A. Dhority, RAC Sr. Regulatory Affairs Specialist Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717
K974728 Re:
Trade Name: Inter-Op™ Metasul® Acetabular System Regulatory Class: III Product Code: KWA Dated: May 20, 1999 Received: May 21, 1999
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 (OS) 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 A. Dhority
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. Furthermore, for questions regarding 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,
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
4
510(k) Number (if known): K974728
Device Name: Inter-Op Metasul Acetabular System
Indications for Use:
P
The Inter-Op Metasul Acetabular System is intended for use in cases of total hip replacement for treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 1. osteoarthritis, post traumatic arthritis or avascular necrosis and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity or dysfunction persists. 2.
- Revision of previously failed hip arthroplasty. 3.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| (Division Sign-Off) | |||
| Division of General Restorative Devices | |||
| 510(k) Number | K994728 | ||
| Prescription Use | OR | Over-the Counter Use |
000017
(Optional Format 1-2-96)