(136 days)
Not Found
No
The summary describes a mechanical implant (femoral stem) and its physical characteristics, materials, and performance in bench testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "femoral stem" intended for "total hip replacement" to "replace the anatomy of the femur" in cases of various joint diseases or failed surgeries. This falls under the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The BetaCone is an implantable prosthetic device (femoral stem) used for total hip replacement, not for diagnosing medical conditions.
No
The device description clearly states it is a physical implant fabricated from titanium alloy, intended for surgical implantation.
Based on the provided information, the BetaCone device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the BetaCone is a device for replacing the anatomy of the femur in total hip replacement. This is a surgical implant, not a device used to perform tests on samples taken from the body (like blood, urine, or tissue) to diagnose a condition.
- Device Description: The description details a physical implant made of titanium alloy, designed for surgical insertion and fixation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used for testing biological samples, analyzing biomarkers, or providing diagnostic information based on in vitro analysis.
Therefore, the BetaCone is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BetaCone is intended for non-cemented use to replace the anatomy of the femur in cases of total hip replacement. It is indicated in the treatment of the following:
- Patient conditions of noninflammatory degenerative joint disease, e.g., avascular necrosis and osteoarthritis; and inflammatory joint disease, e.g., rheumatoid arthritis;
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists; and
- Revision of a previously failed hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
LWJ, JDI
Device Description
Both the BetaCone and the predicate Encore, CLS, and Alloclassic Hip Stems use titanium alloy straight, tapered stems to replace the femur in hip replacement procedures. The BetaCone is fabricated from Ti-6Al-4V titanium alloy. BetaCone stems are available in 9 standard and 9 XL sizes. with lengths ranging from 135 to 175 mm. The BetaCone stem has a rectangular cross-section slightly rounded in both planes. BetaCone XL neck lengths are 5 mm longer than standard stem neck lengths. The Beta Cone neck angle is 126°.
A 12/14 taper connects with Link's prosthesis heads using the same size taper. The BetaCone is compatible with Link standard acetabular cups.
The BetaCone stem is designed for uncemented, press-fit fixation. A proximal trochanter fin supports proximal press-fit fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur
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)
The BetaCone prosthesis was subjected to dynamic fatigue testing in accordance with ISO 7206-4: 2002, using an 80mm potting level. Five samples of the same sized, worst case stem were tested. No prosthesis tested at a maximum load of 2.3kN failed up to 5 million cycles.
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.
K930963, K042249, K010839, K033664, K030373
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.
Not Found
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
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
0
K051826
510(k) SUMMARY
Waldemar Link GmbH & Co. KG's BetaCone™ Hip Prosthesis System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Waldemar Link GmbH & Co. KG Barkhausenweg 10 D-22339 Hamburg Germany Telephone: 49 (0)40 5 39 95-0 49 (0)40 5 38 69 29 Fax:
Peter Keller Contact Person:
Date Prepared: July 5, 2005
Name of Device and Name/Address of Sponsor
BetaCone™ Hip Prosthesis System
Waldemar Link GmbH & Co. KG Barkhausenweg 10 D-22339 Hamburg Germany
Common or Usual Name
Femoral Hip Stem
Classification Name
Hip joint metal/polymer semi-constrained cemented prosthesis, 21 C.F.R. § 888.3350, JDI; Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis, 21 C.F.R. § 888.3360, LWJ.
1
Predicate Devices
Encore Orthopaedics' SL-Plus and SLR-Plus Stems (Encore) (K930963); Centerpulse's CLS Spotorno Stems (CLS) (K042249, K010839); Zimmer's Alloclassic Femoral Stems (Alloclassic) (K033664, K030373).
Intended Use / Indications for Use
The BetaCone is intended for non-cemented use to replace the anatomy of the femur in cases of total hip replacement. It is indicated in the treatment of the following:
- Patient conditions of noninflammatory degenerative joint disease, e.g., � avascular necrosis and osteoarthritis; and inflammatory joint disease, e.g., rheumatoid arthritis;
- Those patients with failed previous surgery where pain, deformity, or � dysfunction persists; and
- Revision of a previously failed hip arthroplasty. .
Technological Characteristics and Substantial Equivalence
Both the BetaCone and the predicate Encore, CLS, and Alloclassic Hip Stems use titanium alloy straight, tapered stems to replace the femur in hip replacement procedures. The BetaCone is fabricated from Ti-6Al-4V titanium alloy. BetaCone stems are available in 9 standard and 9 XL sizes. with lengths ranging from 135 to 175 mm. The BetaCone stem has a rectangular cross-section slightly rounded in both planes. BetaCone XL neck lengths are 5 mm longer than standard stem neck lengths. The Beta Cone neck angle is 126°.
A 12/14 taper connects with Link's prosthesis heads using the same size taper. The BetaCone is compatible with Link standard acetabular cups.
The BetaCone stem is designed for uncemented, press-fit fixation. A proximal trochanter fin supports proximal press-fit fixation.
The BetaCone is substantially equivalent to the other currently marketed femoral hip stems which are referenced above. The BetaCone and its predicate devices have the same intended use and indications for use; all are titanium alloy, straight, tapered stems available in a similar range of sizes and employing the same essential design geometry. Thus, the BetaCone raises no new issues of safety or effectiveness.
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and the country of the count
:
・
Performance Data – Bench Testing
i
:
.......
The BetaCone prosthesis was subjected to dynamic fatigue testing in accordance with ISO 7206-4: 2002, using an 80mm potting level. Five samples of the same sized, worst case stem were tested. No prosthesis tested at a maximum load of 2.3kN failed up to 5 million cycles.
ੁ *
3
Public Health Service
Image /page/3/Picture/3 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus symbol.
NOV 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Waldemar Link GmbH & Co. KG c/o Janice M. Hogan, Partner Hogan & Hartson L.L.P. 1835 Market Street, 28th Floor Philadelphia, Pennsylvania 19103
Re: K051826
Trade/Device Name: BetaCone™ Hip Prosthesis System Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: II Product Code: LWJ, JDI Dated: November 2, 2005 Received: November 2, 2005
Dear Ms. Hogan:
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 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting 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 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with 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 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.
4
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milken
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):_ K05-1826
Device Name: BetaCone™ Hip Prosthesis System
Indications for Use:
The BetaCone is intended for non-cemented use to replace the anatomy of the femur in cases of total hip replacement. It is indicated in the treatment of the following:
- Patient conditions of noninflammatory degenerative joint disease, e.g., . avascular necrosis and osteoarthritis; and inflammatory joint disease, e.g.,
The unstailers the its it is it inflammatory joint disease, e.g., rheumatoid arthritis; - Those patients with failed previous surgery where pain, deformity, or ● dysfunction persists; and
- Revision of a previously failed hip arthroplasty. .
Mark A. Molkerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
4 5 2.3 18
Prescription Use _ V (Per 21 C.F.R. 801.109)
AND/OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PH - 67488/0006 - 19265