(87 days)
No
The description focuses on the material, design, and mechanical properties of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an acetabular cup intended for hip joint replacement due to various arthritic conditions, effectively treating or managing a disease.
No
The device is an implantable acetabular cup intended for hip joint replacement, not for diagnostic purposes.
No
The device description clearly details a physical implant (acetabular cup, inserts, screws) made of titanium and UHMWPE, which are hardware components. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description and Intended Use: The provided text describes a physical implantable device (an acetabular cup for hip replacement surgery). Its intended use is to replace a damaged hip joint. This is an in vivo device, meaning it is used within the living body.
The description clearly indicates a surgical implant, not a device used to test samples outside the body.
N/A
Intended Use / Indications for Use
The MPF Acetabular Cup is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.
Product codes (comma separated list FDA assigned to the subject device)
LZO, LWJ
Device Description
The MPF Acetabular Cup is a cementless, press-fit cup. It is available in 10 sizes ranging from 46 mm to 64 mm in 2 mm increments. It is manufactured from CP Titanium according to ASTM F 67. UHMWPE inserts are available in neutral and 20° hooded versions. Cancellous bone screws from Ti6Al4V are available in 7 sizes ranging from 20 mm to 50 mm in length. They have a standard 6.5 mm thread diameter and 3.5 mm core diameter. The cup has 3 screw holes for optional fixation. The open, unused screw holes can be closed with threaded screw hole covers. The MPF cup may be used with the following ball heads manufactured by PLUS and INTRAPLANT that are cleared for marketing by the U.S. FDA: CS-PLUS® Stem with CoCrMo Ball Head (K936214 - 6/15/94) SL/SLR-PLUS® Stem with CoCrMo Ball Head (K932481 - 6/8/94) SL/SLR-PLUS® Stem with Biolox Ceramic Head (K930963 - 17794) INTRAPLANT Ceramic Ball Heads (K990261 - 8/27/99) MODULAR-PLUS® Revision Stem (K994126 - 5/4/00) PLUS CoCrMo Ball Heads (K001942 - 7/25/00)
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)
Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading.
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.
K936214, K932481, K930963, K990261, K994126, K001942
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
KD11836
SEP - 7 2001
510(k) Summary of Safety and Effectiveness
[in accordance with SMDA of 1990, 21 CFR 807.92(c)]
Contact:
PLUS ORTHOPEDICS 6055 Lusk Blvd. San Diego, CA 92121 Tel: 858-550-3800 – Fax: 858-550-3813 Attn: Mr. Hartmut Loch, RAC Director, Regulatory Affairs
Trade name:
Classification
name:
MPF Acetabular Cup
Acetabular Cup Common name:
Hip joint metal/polymer semi-constrained uncemented prosthesis. & 888.3353, Class II, Orthopedic Device Panel 87
LZO & LWJ Product Code:
Device Description and Characteristics: The MPF Acetabular Cup is a cementless, press-fit cup. It is available in 10 sizes ranging from 46 mm to 64 mm in 2 mm increments. It is Sizos Tanging Trom CP Titanium according to ASTM F 67. UHMWPE inserts are available in neutral and 20° hooded versions. Cancellous bone inforts are a from Ti6Al4V are available in 7 sizes ranging from 20 mm to 50 mm in length. They have a standard 6.5 mm thread diameter and 3.5 00 mm in long.m The cup has 3 screw holes for optional min octagonal ocrantion. The open, unused screw holes can be closed with threaded screw hole covers. The MPF cup may be used with the following ball heads manufactured by PLUS and INTRAPLANT that are cleared for marketing by the U.S. FDA: CS-PLUS® Stem with CoCrMo Ball Head (K936214 - 6/15/94) SL/SLR-PLUS® Stem with CoCrMo Ball Head (K932481 - 6/8/94) SL/SLR-PLUS® Stem with Biolox Ceramic Head (K930963 - 17794) INTRAPLANT Ceramic Ball Heads (K990261 - 8/27/99) MODULAR-PLUS® Revision Stem (K994126 - 5/4/00) PLUS CoCrMo Ball Heads (K001942 - 7/25/00)
- The MPF Acetabular Cup is substantially equivalent to the LPC-PLUS Equivalence: Acetabular Cup (K003274 - S/E 4/6/2001). Both cups are similar in design. They both are manufactured from CP Titanium conforming to ASTM F67 and are Ti-Plasma coated. In addition, both cups are for uncemented use and are intended for the same medical indications.
The MPF Acetabular Cup is intended for uncemented use for all types of Indications: arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.
Biomechanical tests have been performed. The test results were equivalent Performance data: to other similar implants and are sufficient for in vivo loading.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design, with three curved lines forming the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.
SEP - 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Helmut Loch, RAC Director, Regulatory Affairs PLUS Orthopedics 6055 Lusk Boulevard San Diego, California 92121
Re: K011836
Trade/Device Name: MPF Acetabular Cup Regulation Number: 888.3353 Regulation Name: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Regulatory Class: II Product Code: LZO, LWJ Dated: June 8, 2001 Received: June 12, 2001
Dear Mr. Loch:
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 legally marketed predicate devices marketed in interstate commerce beated in the enormers of 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 orovisions 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 (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 requirements, 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.
2
Page 2 - Mr. Helmut Loch, 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".
Sincerely yours,
Sasa Wal, N
Image /page/2/Picture/5 description: The image contains a handwritten letter 'k' in a simple, cursive style. The letter is drawn with a single stroke for the vertical line and a connected, curved stroke for the angled lines that form the rest of the letter. The letter appears to be written with a pen or marker, and the lines are smooth and consistent.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number: KØ11836
Device Name(s):
MPF ACETABULAR CUP
Indications for Use:
The MPF Acetabular Cup is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, annous, and or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sll
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
Prescription Use
510(k) Number /1011834
OR Over-The-Counter-Use
(Per 21 CFR 801.109)
(Optional format 1-2-96)