(87 days)
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.
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 manufactured 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. 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)
The provided 510(k) summary (K011836) for the MPF Acetabular Cup is for a medical device that replaces part of a hip joint. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through a clinical study or complex algorithm validation. Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory document.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This section is not applicable in the context of this 510(k) submission. The document states:
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence to Predicate Device | Design, Manufacturing Material (CP Titanium, Ti-Plasma coated), Uncemented Use, Intended Medical Indications are similar to predicate device (LPC-PLUS Acetabular Cup, K003274). | "The MPF Acetabular Cup is substantially equivalent to the LPC-PLUS 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." |
| Biomechanical Performance | Equivalent to other similar implants; sufficient for in vivo loading. | "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading." |
Note: For medical devices cleared via 510(k), especially for implants like this, the focus is often on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than meeting novel performance criteria established through efficacy studies. Performance is often assessed through bench testing (biomechanical, material compatibility, etc.) and comparison to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This device relies on biomechanical testing and comparison to a predicate, not a clinical "test set" in the context of algorithm performance or clinical trial data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. "Ground truth" in the context of clinical expert consensus for image analysis or diagnostic algorithms is not relevant for this device. The regulatory review process involves FDA experts, but that's a different context.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the sense of clinical cases requiring adjudication for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is not mentioned and is typically not applicable for a hip replacement component. This type of study is more common for diagnostic imaging algorithms.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical device (an acetabular cup for hip replacement), not a software algorithm.
7. Type of Ground Truth Used
For the biomechanical tests, the "ground truth" would be established by engineering standards and accepted biomechanical principles for orthopedic implants (e.g., ability to withstand physiological loads, fatigue resistance, material properties meeting ASTM standards).
For the substantial equivalence claim, the "ground truth" is the performance and safety profile of the predicate device.
8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of machine learning or algorithms for this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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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.
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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.
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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
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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)
§ 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.