(106 days)
No
The document describes a modular hip implant system and a reinforcement ring, focusing on materials, design, and intended use in revision hip arthroplasty. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is an orthopedic implant (Prevision Hip System and Recon Ring) intended for the reconstruction of joints, specifically for hip arthroplasty in cases of advanced joint destruction or failed previous surgeries, which directly addresses a medical condition to restore function.
Yes
The "Diagnostic indications for use of this device include acetabular dysplasia, osteoporosis, protrusion acetabuli, cystic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery." statement directly indicates its diagnostic purpose.
No
The device description clearly states it is a modular system consisting of physical components (proximal body, distal stem, tension nut, Recon Ring) made of Titanium Alloy, intended for surgical implantation. This is a hardware medical device.
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 (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Prevision Hip System and Recon Ring are surgical implants intended for use within the human body during hip revision surgery. They are used to reconstruct and support the hip joint.
- Lack of Specimen Analysis: There is no mention of this device analyzing any biological specimens. Its function is purely mechanical and structural within the body.
- Intended User and Setting: The device is used by a surgeon in an operating room, which is consistent with a surgical implant, not an IVD.
The diagnostic indications listed for the Recon Ring refer to the conditions for which the device might be used during surgery, not that the device itself performs a diagnostic test.
N/A
Intended Use / Indications for Use
The Prevision Hip System is intended for cementless revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The Prevision Hip System is intended for revision only.
The Recon Ring is intended to bridge the areas of acetabular bone loss in patients with acetabular bone deficiency. In addition, the Recon Ring is intended to provide support for an all polyethylene acetabular implant in a cemented application.
Diagnostic indications for use of this device include acetabular dysplasia, osteoporosis, protrusion acetabuli, cystic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery.
The general indications associated with the use of the Recon Ring in total hip arthroplasty include:
- Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid . arthritis.
- . Fracture or avascular necrosis of the femoral head,
- Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-● arthroplasty and total hip replacement.
Product codes
MEH, JDI, LWJ, LZO, KWY
Device Description
The Prevision Hip System is a modular system which consists of a proximal body, distal stem and a tension nut. The three individual components utilize a modular junction. The individual components may be assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal stem. All proximal components are able to mate with all distal components providing a comprehensive range of combinations offering optimal flexibility. It is designed for use with currently available Aesculap Implant Systems femoral heads, acetabular components and Bipolar cups.
The Prevision Hip System is manufactured from Titanium Alloy and intended for cementless use. The proximal body is plasma sprayed (Plasmapore®) with a secondary coating of Calcium Phosphate (u-CaP®).
The Recon Ring will be offered in three sizes with left and right configurations. The Recon Ring is manufactured from Titanium. It is designed to be used with the PE acetabular cup cleared in BiContact (K040191).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral head, neck, proximal femur, acetabular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, operating room
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)
Testing of the Aesculap Implant Systems Prevision Hip System was performed in accordance with ISO 7206 and ASTM F 2068 and the results were found to be similar to other legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K992667, K994286, K960678, K071916, K040191
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K102424 (pg 1/2)
Page 1 of 2
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
DEC - 9 2010
Prevision Hip System with Recon Ring December 3, 2010
| COMPANY: | Aesculap Implant Systems, LLC
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 3005673311 |
| ---------- | ------------------------------------------------------------------------------------------------------------------------------------- |
|---|
CONTACT: Kathy A. Racosky 610-984-9291 (phone) 610-791-6882 (fax) Kathy.racosky@aesculap.com
TRADE NAME: Prevision Hip System
COMMON NAME: Femoral Hip Prosthesis
CLASSIFICATION NAME: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate Prosthesis, Hip, Semi-constrained, Metal/Polymer, Cemented Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented or Uncemented
888.3353, 888.3350, 888.3360, 888.3353, 888.3390, REGULATION NUMBER:
PRODUCT CODE: MEH, JDI, LWJ, LZO, KWY
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems, LLC believes that the Prevision Hip System with Recon Ring is substantially equivalent to:
- Zimmer, Inc. ZMR Hip System (K992667 & K994286) ●
- Intermedics Orthopedics Inc., Burch/Schneider Reinforcement Cage (K960678) .
- Aesculap Implant Systems Metha Hip System (K071916) .
- Aesculap Implant Systems Bicontact (K040191) .
DEVICE DESCRIPTION
The Prevision Hip System is a modular system which consists of a proximal body, distal stem and a tension nut. The three individual components utilize a modular junction. The individual components may be assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal stem. All proximal components are able to mate with all distal components providing a comprehensive range of combinations offering optimal flexibility. It is designed for use with currently available Aesculap Implant Systems femoral heads, acetabular components and Bipolar cups.
1
Page 2 of 2
The Prevision Hip System is manufactured from Titanium Alloy and intended for cementless use. The proximal body is plasma sprayed (Plasmapore®) with a secondary coating of Calcium Phosphate (u-CaP®).
The Recon Ring will be offered in three sizes with left and right configurations. The Recon Ring is manufactured from Titanium. It is designed to be used with the PE acetabular cup cleared in BiContact (K040191).
PURPOSE FOR PREMARKET NOTIFICATION
The purpose for this submission is to gain marketing clearance for the Aesculao Implant Systems Prevision Hip System with Recon Ring.
INDICATIONS FOR USE
The Prevision Hip System is intended for cementless revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The Prevision Hip System is intended for revision only.
The Recon Ring is intended to bridge the areas of acetabular bone loss in patients with acetabular bone deficiency. In addition, the Recon Ring is intended to provide support for an all polyethylene acetabular implant in a cemented application.
Diagnostic indications for use of this device include acetabular dysplasia, osteoporosis, protrusion acetabuli, cvstic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery.
The general indications associated with the use of the Recon Ring in total hip arthroplasty include:
- Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid . arthritis.
- . Fracture or avascular necrosis of the femoral head,
- Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-● arthroplasty and total hip replacement.
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s)}
The components of the Aesculap Implant Systems Prevision Hip System with Recon Ring are offered in a similar range of shapes and sizes as the predicate devices. The material used for the Aesculap Implant Systems device is the same as that used to manufacture the predicate devices.
PERFORMANCE DATA
Testing of the Aesculap Implant Systems Prevision Hip System was performed in accordance with ISO 7206 and ASTM F 2068 and the results were found to be similar to other legally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aesculap Implant Systems LLC % Ms. Kathy A. Racosky 3773 Corporate Parkway Center Valley, PA 18034
DEC - 9 2010
Re: K102424
:
Trade/Device Name: Prevision Hip System with Recon Ring 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: MEH, JDI, LWJ, LZO, KWY Dated: December 3, 2010 Received: December 6, 2010
Dear Ms. Racosky:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regarly manatinent date of the Medical Device Amendments, or to commerce province to May 26, 1976, the enasting with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosment Act (Act) that to not require approvinces of the general controls provisions of the Act. The You may, merelore, market the device, subject to the genirements for annual registration, listing of general controls provisions of the rict liveling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Prease note: CDICT does not over be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
es an be If your device is classified (Scc above) fine viar regulations affecting your device can be
may be subject to additional controls. Existing major regulations addition, EDA m may be subject to additions: Existing mays. Existing mays found in the Code of I cucral Rogarations) This Levice in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualitat equr device of a success at
that FDA has made a determination that your device complies with other requirements of the Act
3
Page 2 - Ms. Kathy A. Racosky
I uge 2 - Ms. Ratily in Not regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm1.
Sincerely yours,
Sincerely yours,
{}
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT A.
DEC - 9 2010
510(k) Number: K102424(pg 1/1)
Device Name: Prevision Hip System with Recon Ring
Indications for Use:
The Prevision Hip System is intended for cementless revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The Prevision Hip System is intended for revision only.
The Recon Ring is intended to bridge the areas of acetabular bone loss in patients with acetabular bone deficiency. In addition, the Recon Ring is intended to provide support for an all polyethylene acetabular implant in a cemented application.
Diagnostic indications for use of this device include acetabular dysplasia, osteoporosis, protrusion acetabuli, cystic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery.
The general indications associated with the use of the Recon Ring in total hip arthroplasty include:
- Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid ● arthritis.
- Fracture or avascular necrosis of the femoral head, �
- Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-. arthroplasty and total hip replacement.
| Prescription Use | X |
|---|---|
| and/or Over-the-Counter 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 Evaluation (ODE)
Apr M. Wilkerson
(Division Sign-Off (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102424