(41 days)
Not Found
No
The device description focuses on the materials and mechanical design of a hip implant component, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for total hip arthroplasty to treat various joint diseases and failed previous surgeries, which clearly falls under therapeutic use.
No
The device is an orthopedic implant (acetabular insert) used in total hip arthroplasty, which is a treatment, not a diagnostic procedure. Its purpose is to replace a diseased or damaged joint, not to identify or characterize a medical condition.
No
The device description clearly states it is a modular metal insert made from physical materials (polyethylene, CoCrMo alloy, CoCr alloy) and has specific physical dimensions and features for implantation in the hip joint. It is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for surgical implantation in total hip arthroplasty. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical implantable device made of metal and polyethylene, designed to be part of a hip joint replacement. This is consistent with a surgical implant, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory testing.
Therefore, the APR Metasul Acetabular Inserts are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The APR Metasul Acetabular Inserts are intended for use with the APR Acetabular Shells and Metasul femoral heads in total hip arthroplasty for treatment of the following:
- patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular ● necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- those patients with failed previous surgery where pain, deformity, or dysfunction persists. .
- revision of a previously failed arthroplasty. .
Product codes
KWA
Device Description
The APR Metasul Acetabular Insert is a modular metal insert which is hemispherical in shape and has an outer diameter manufactured from polyethylene (UHMWPE, ASTM F648). The outer diameter of the insert is machined with locking features that mate with one of the previously cleared APR metallic acetabular shells.
The inner diameter which forms the bearing surface of this insert features a metallic Metasul inlay that is integrally locked to the polyethylene portion. The metal inlay is manufactured from Protasul"-21WF, a wrought forged CoCrMo alloy (ISO 5832-4, ISO 5832-12). This inlay is polished to a mirror-finish and hot-pressed into the UHMWPE backing. Just prior to hot-pressing, two Protasul-10 (CoCr alloy, ASTM F562) pins may be press fit into the design of the inlay to help provide added rotational stability. As a result of the strictly controlled tolerances of the inlay and in order to recognize the beneficial wear properties associated with this component, this insert is designed for use only with previously cleared head components.
The APR Metasul Acetabular Insert component is available with outside diameters of 49mm to 81mm (in 2mm increments) with an inner diameter of 28mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
APR Acetabular System, Inter-Op Metasul Acetabular System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC - I 1999
510(k) SUMMARY
| Sponsor: | Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 |
|-------------------------|--------------------------------------------------------------------------------------------------------|
| 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 APR Metasul Acetabular Inserts |
PRODUCT DESCRIPTION
The APR Metasul Acetabular Insert is a modular metal insert which is hemispherical in shape and has an outer diameter manufactured from polyethylene (UHMWPE, ASTM F648). The outer diameter of the insert is machined with locking features that mate with one of the previously cleared APR metallic acetabular shells.
The inner diameter which forms the bearing surface of this insert features a metallic Metasul inlay that is integrally locked to the polyethylene portion. The metal inlay is manufactured from Protasul"-21WF, a wrought forged CoCrMo alloy (ISO 5832-4, ISO 5832-12). This inlay is polished to a mirror-finish and hot-pressed into the UHMWPE backing. Just prior to hot-pressing, two Protasul-10 (CoCr alloy, ASTM F562) pins may be press fit into the design of the inlay to help provide added rotational stability. As a result of the strictly controlled tolerances of the inlay and in order to recognize the beneficial wear properties associated with this component, this insert is designed for use only with previously cleared head components.
The APR Metasul Acetabular Insert component is available with outside diameters of 49mm to 81mm (in 2mm increments) with an inner diameter of 28mm.
INTENDED USE / DIAGNOSTIC INDICATIONS
The APR Metasul Acetabular Inserts are intended for use with the APR Acetabular Shells and Metasul femoral heads in total hip arthroplasty for treatment of the following:
- patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular ● necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- those patients with failed previous surgery where pain, deformity, or dysfunction persists. .
- revision of a previously failed arthroplasty. .
SUBSTANTIAL EQUIVALENCE
Substantial equivalence is based on a direct comparison to the commercially APR Acetabular System and Inter-Op Metasul Acetabular System. The fundamental scientific technologies
1
incorporated into these two products has not changed in the APR Metasul Acetabular Insert. Based on conformance with the design control requirements as specified in 21 CFR 820.30 and similarities in design, materials, sterilization, method of manufacture, intended use and indications for use, we believe that the APR Metasul Acetabular Insert is substantially equivalent to the previously cleared APR Acetabular System and Inter-Op Metasul Acetabular System.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 1 1999
Mitchell A. Dhority, RAC Manager, Regulatory and Clinical Affairs Sulzer Medica Sulzer Orthopedics Inc. 9900 Spectrum Drive Austin, Texas 78717
K993569 Re: APR Metasul Acetabular Insert Trade Name: Requlatory Class: III Product Code: KWA Dated: November 15, 1999 November 16, 1999 Received:
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 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 Regulations, Title 21, Parts 800 to 895. ಗ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq 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.
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Page 2 - Mitchell A. Dhority, RAC
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 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Irvine F. Dillard III
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_____gg3569
Device Name: APR Metasul Acetabular Inserts
Indications for Use:
The APR Metasul Acetabular Inserts are intended for use with the APR Acetabular Shells and Metasul femoral heads in total hip arthroplasty for treatment of the following:
-
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 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.
-
- Revision of previously failed hip arthroplasty.
(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 | K943569 |
× Prescription Use
OR
Over-the Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)