(28 days)
The Excia Hip System is intended to replace a hip joint. The device is intended for: Patients suffering from severe hip and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis Patients suffering from disability due previous fusion Patients with acute femoral neck fractures. The Metha® Hip System (uncemented, press-fit fixation) is Intended to replace a hip joint. The device is intended for: skeletally mature individuals undergoing primary surgery for total hip replacement patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur, patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis patients suffering from disability due to previous fusion patients with acute femoral neck fractures. Indications for use of the CONSENSUS® HIP SYSTEM-PRIMARY HIP: A) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic arthritis. B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. C) Proximal femoral fractures. D) Avascular necrosis of the femoral head. E) Non-union of proximal femoral neck fractures. F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteoporosis, pseudarthrosis conversion, and structural abnormalities. Acetabular components are indicated for cemented and cementless use.
The Consensus Acetabular Cup from Hayes Medical is a Titanium alloy shell with a highly cross linked polyethylene insert. The Consensus acetabular cups are available in 28mm, 32mm, and 36mm ID's, a variety of sizes, and in either standard or hooded versions. The shells are available with or without screws. The Aesculap Excia hip systems also comes in 28mm - 36 mm ID's, it is available in both cemented and uncemented variants, and a wide range of sizes. Aesculap's Metha hip system also comes in 28 - 36 mm ID's but is for uncemented use, and also comes in a variety of sizes. The PlasmaCup acetabular cup from Aesculap is cleared for use with both the Excia and Metha systems.
This document describes the 510(k) summary for the Consensus Acetabular Cups for use with Aesculap Excia and Metha Hip Systems. It outlines the substantial equivalence to previously cleared devices based on technological characteristics and engineering evaluation, rather than new performance data from a specific study.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria or performance metrics (e.g., accuracy, sensitivity, specificity for diagnostic devices; or mechanical test results for orthopedic implants) are listed in the document. The filing is based on the substantial equivalence of the device's design to existing cleared devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. | Not applicable. |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical study yielding performance data was conducted or described in this 510(k) submission for the Consensus Acetabular Cups. The submission relies on the engineering evaluation of dimensions and the equivalence to previously cleared devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable, as no new performance data requiring ground truth establishment from experts was generated or presented in this submission.
4. Adjudication Method
Not applicable, as no new performance data requiring adjudication was generated or presented.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or described. This K081978 submission is for an orthopedic implant and does not involve AI or human-in-the-loop performance evaluation.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is an orthopedic implant, not an algorithm.
7. Type of Ground Truth Used
Not applicable, as no primary performance study needing ground truth was performed for this submission. The basis for clearance is technological equivalence and previous clearances.
8. Sample Size for the Training Set
Not applicable. This device is an orthopedic implant, and there is no mention of a training set as would be relevant for an AI/algorithm-based device.
9. How Ground Truth for the Training Set Was Established
Not applicable, as no training set or ground truth for such a set is mentioned.
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510(k) SUMMARY (as required by 21 CFR 807.92) B.
Consensus Acetabular Cups in Aesculap Hip Systems AUG - 7 2008 8 July 2008
| COMPANY: | Aesculap® Implant Systems, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311 |
|---|---|
| CONTACT: | Matthew M. Hull800-258-1946 (phone)610-791-6882 (fax)matt.hull@Aesculap.com (e-mail) |
| TRADE NAME: | Excia and Metha Hip Systems (Consensus Acetabular Cup |
| COMMON NAME: | Total Hip System |
| CLASSIFICATION NAME: | Prosthesis, hip, semi-constrained, metal/ceramic/polymer,cemented or non-porous uncemented prosthesisProsthesis, hip, semi-constrained, metal/polymer, porousuncemented |
- 888.3353/ 888.3358 REGULATION NUMBER:
- LZO/ LPH PRODUCT CODE:
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Consensus Acetabular Cup is a line extension of Aesculap's Excia (K042344 - K062684) and Metha (K071916 & K080584) Hip Systems that were previously cleared for use with acetabular cups. The Consensus Acetabular Cup components have been cleared in K020153 – K070061 for use with the Consensus and Unisyn hip systems from Hayes Medical.
DEVICE DESCRIPTION
The Consensus Acetabular Cup from Hayes Medical is a Titanium alloy shell with a highly cross linked polyethylene insert. The Consensus acetabular cups are available in 28mm, 32mm, and 36mm ID's, a variety of sizes, and in either standard or hooded versions. The shells are available with or without screws. The Aesculap Excia hip systems also comes in 28mm - 36 mm ID's, it is available in both cemented and uncemented variants, and a wide range of sizes. Aesculap's Metha hip system also comes in 28 - 36 mm ID's but is for uncemented use, and also comes in a variety of sizes. The PlasmaCup acetabular cup from Aesculap is cleared for use with both the Excia and Metha systems.
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K081978 (pg 2/2)
INDICATIONS FOR USE
The Excia Hip System is intended to replace a hip joint. The device is intended for:
· Patients suffering from severe hip and disability due to rheumatord arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
-
· Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis
· Patients suffering from disability due previous fusion -
· Patients with acute femoral neck fractures
The Excia Hip System is available with two femoral stems. One is manufactured from CoCMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from TT with Plasmapore with or without u CaP®.
The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip joint.
The device is intended for:
-
· skeletally mature individuals undergoing primary surgery for total hip replacement
· patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, -
polvarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
-
· patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis
-
· patients suffering from disability due to previous fusion
• patients with acute femoral neck fractures
Indications for use of the CONSENSUS® HIP SYSTEM-PRIMARY HIP:
A) Significantly impaired joints resulting from rheumatoid, osteo, and positraumatic arthritis.
B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
- C) Proximal femoral fractures.
- D) Avascular necrosis of the femoral head.
- E) Non-union of proximal femoral neck fractures.
F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa valga, developmental conditions, metabolic and tumorous conditions, osteoporosis, pseudarthrosis conversion, and structural abnormalities.
Acetabular components are indicated for cemented and cementless use.
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))
There are no changes to the Hayes Consensus acetabular cup nor to the Aesculap Excia and Metha hip systems. The inner dimensions of the Aesculap PlasmaCup acetabular cup inserts are identical to those of the Hayes Consensus acetabular cups. The difference is that the Consensus inserts are highly crosslinked polyethylene (UHMWPE) and the Aesculap PlasmaCup inserts are regular polyethylene (UHMWPE).
PERFORMANCE DATA
Based upon the engineering evaluation of the dimensions of these components no additional performance data was required.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three overlapping, curved lines representing its wings. The words "DEPARTMENT OF HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
800 - 1000 - 100
AUG - 7 2008
Aesculap Implant Systems, Inc. % Mr. Matthew M. Hull, RAC Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034
K081973 Re:
Trade/Device Name: Consensus Acetabular Cups for use with the Aesculap Excia and Metha Hip Systems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO, LPH Dated: July 9, 2008 Received: July 10, 2008
Dear Mr. Hull:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assessment 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) that do not require approval of a premarket approval application (PMA). and Oosmetier fore, market the device, subject to the general controls provisions of the Act. The Tota may, ateres 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 (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of actived that I B r mination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any i vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Mr. Matthew M. Hull, RAC
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millison
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT A.
Image /page/4/Picture/3 description: The image shows the 510(k) number, which is K081973. The number is followed by the page number, which is 1/1. The text is written in black ink on a white background. The text is slightly blurry, but still legible.
Device Name: Consensus Acetabular Cups for use with the Aesculap Excia and Metha Hip Systems
Indications for Use:
The Excia Hip System is intended to replace a hip joint.
The device is intended for:
Patients suffering from severe hip and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis
- Patients suffering from disability due previous fusion ◆
- Patients with acute femoral neck fractures .
The Excia Hip System is available with two femoral stems. One is manufactured from CoCMo and is intended for cemented fixation. The other temoral stor uncemented fixation and manufactured from Ti with Plasmapore with of without u CaP®.
The Metha® Hip System (uncemented, press-fit fixation) is Intended to replace a hip joint.
The device is intended for:
-
skeletally mature individuals undergoing primary surgery for total hip replacement
patients suffering from severe hip pain and disability due to meumatoid arthritis, traumatic arthritis, -
polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur, patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis
-
patients suffering from disability due to previous fusion
-
patients with acute femoral neck fractures
Indications for use of the CONSENSUS® HIP SYSTEM-PRIMARY HIP:
A) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic arthritis.
- B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
- C) Proximal femoral fractures.
- D) Avascular necrosis of the femoral head.
- E) Non-union of proximal femoral neck fractures.
F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteoporosis, pseudarthrosis conversion, and structural abnormalities.
Acetabular components are indicated for cemented and cementless use.
x and/or Over-the-Counter Use Prescription Use
(per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device E
Barbara Breen
Division Sign-Off
and Neurological Devices
510(k) Number K081977³ 002
§ 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.