(26 days)
Not Found
No
The document describes a mechanical implant (femoral stem) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
This device is a prosthetic replacement (femoral stem) used in hip arthroplasty to treat various joint diseases and correct post-surgical issues, directly addressing and rectifying a medical condition.
No
The document describes a femoral stem, which is an implant used in joint replacement surgery, not a tool used to diagnose a condition.
No
The device description clearly indicates it is a physical femoral stem made of titanium alloy, intended for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a prosthetic replacement for treating various joint conditions and failed surgeries. This is a surgical implant, not a test performed on samples taken from the body.
- Device Description: The description details a femoral stem, a physical implant made of titanium alloy. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a physical implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
The Alloclassic Zweymüller SL Offset Femoral Stem is intended for non-cemented use to replace the anatomy of the femur in cases of total hip replacement. It is intended to be used with the anatomy of the formal and metallic or ceramic femoral heads possessing a 12/14 taper.
The indications for use of the Alloclassic Zweymüller SL Offset Femoral Stem are for treatment of the following:
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular ♥ necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- those patients with failed previous surgery where pain, deformity, or dysfunction persists. .
- revision of a previously failed hip arthroplasty. .
- patients who require a total hip replacement. .
Product codes (comma separated list FDA assigned to the subject device)
LZO, JDI, KWY, KWL
Device Description
The Alloclassic Zweymüller SL Offset Femoral Stem is very similar to the previously cleared Alloclassic Zweymüller SL Femoral Stem in that it is:
- a conically shaped straight stem with a rectangular cross section (for rotational stability). 1.
- the same design, distal to the line of resection. 2.
- manufactured from wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11/ASTM 3. F1295).
- grit blasted, below the neck, to enhance the bone-prosthesis interface. 4.
In contrast, this stem provides an additional 6.25mm of offset (per size) and has a CCD/neck angle of 121° (vs. 131° for SL stem). Overall, this new design provides a higher offset sometimes needed for:
-
- correcting insufficient soft tissue balancing,
-
- restoration of leg length, and
- sufficient joint stability following total hip arthroplasty. 3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur, Hip
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)
Not Found
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.
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
§ 888.3353 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
DEC 1 7 2003
PAGE 1 of 2
510(k) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Centerpulse Orthopedics Ltd. Alloclassic™ Zweymüller™ SL Offset Femoral Stem.
| Manufacturer: | Centerpulse Orthopedics Ltd.
Altgasse 44
CH-6340 Baar, Switzerland |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------|
| US Distributor: | Centerpulse Orthopedics Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 |
| Date: | November 20, 2003 |
| Contact Person: | Jean Asquith
Regulatory Affairs Specialist
(512) 432-9900 X8212 |
| Classification Name: | 21 CFR Part 888.3353 - Hip joint metal/ceramic/polymer semi-
constrained cemented or nonporous uncemented prosthesis |
| Common/Usual Name: | Femoral Hip Stem |
| Trade/Proprietary Name: | AlloclassicTM ZweymüllerTM SL Offset Femoral Stem |
PRODUCT DESCRIPTION
The Alloclassic Zweymüller SL Offset Femoral Stem is very similar to the previously cleared Alloclassic Zweymüller SL Femoral Stem in that it is:
- a conically shaped straight stem with a rectangular cross section (for rotational stability). 1.
- the same design, distal to the line of resection. 2.
- manufactured from wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11/ASTM 3. F1295).
- grit blasted, below the neck, to enhance the bone-prosthesis interface. 4.
In contrast, this stem provides an additional 6.25mm of offset (per size) and has a CCD/neck angle of 121° (vs. 131° for SL stem). Overall, this new design provides a higher offset sometimes needed for:
-
- correcting insufficient soft tissue balancing,
-
- restoration of leg length, and
- sufficient joint stability following total hip arthroplasty. 3.
1
133664
Page 2 of 2
SPECIFIC DIAGNOSTIC INDICATIONS
There have been no changes in the diagnostic indications for use as compared to the unmodified device.
The Alloclassic Zweymüller SL Offset Femoral Stem is intended for non-cemented use to replace the anatomy of the femur in cases of total hip replacement. It is intended to be used with the anatomy of the formal and metallic or ceramic femoral heads possessing a 12/14 taper.
The indications for use of the Alloclassic Zweymüller SL Offset Femoral Stem are for treatment of the following:
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular ♥ necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- those patients with failed previous surgery where pain, deformity, or dysfunction persists. .
- revision of a previously failed hip arthroplasty. .
- patients who require a total hip replacement. .
SUBSTANTIAL EQUIVALENCE
Therefore, based on the information provided, Centerpulse Orthopedics believes the Alloclassic Therefore, SL Offset Fernoral Stem is substantially equivalent to the previously cleared, Zweymäller SL Femoral Stem (ref. K030373 as Exhibit 3) as it has the same indications for use, basic design, sizes, material, sterilization method, and method of manufacture.
2
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or a stylized human figure. The image is in black and white.
DEC 17 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jean Asquith Regulatory Affairs Specialist Centerpulse Orthopedics Inc. 9900 Spectrum Drive Austin, Texas 78717
Re: K033664 R05500+
Trade/Device Name: Alloclassic" Zweymüller"" SL Offset Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Codes: LZO, JDI, KWY, KWL Dated: November 20, 2003 Received: November 21, 2003
Dear Ms. Asquith:
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, 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Codc 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.
3
Page 2 - Ms. Jean Asquith
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
b. Mark N. Millburn
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
4
Page 1 of 1
510(k) Number (if known):
Device Name: Alloclassic SL Offset Femoral Stem
Indications for Use:
The Alloclassic SL Offset Femoral Stem is intended for prosthetic replacement without bone cement in treatment of the following:
- patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular . necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- those patients with failed previous surgery where pain, deformity, or dysfunction persists. .
- revision of a previously failed hip arthroplasty. .
- patients who require a total hip replacement. .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √
OR
Over-The-Counter Use
Mark n Millken
(Optional Format 1-2-96)
Division Sign-Off
Division of General, Restorative
and Neurological Devices
Number K033