(30 days)
Not Found
No
The 510(k) summary describes a mechanical orthopedic implant (femoral stem) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device, a femoral stem, is intended for prosthetic replacement in serious conditions like degenerative joint disease and failed surgeries, directly addressing and treating physical ailments.
No
Explanation: The Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is an implantable prosthetic device for hip replacement, not a device used to diagnose a medical condition.
No
The device description clearly describes a physical femoral stem made of titanium alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is a physical implant designed to replace a portion of the femur (thigh bone) in hip replacement surgery. It is a surgical device, not a diagnostic test.
- Intended Use: The intended use clearly describes its purpose as a prosthetic replacement for treating various hip conditions and failed surgeries. This is a therapeutic intervention, not a diagnostic one.
The information provided describes a surgical implant used directly within the body, which falls under the category of a medical device, but specifically not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Alloclassic™ Zweymueller® SL/SLL 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 Centerpulse Orthopedics acetabular components and metallic or ceramic femoral heads possessing a 12/14 taper.
The indications for use of the Alloclassic™ Zweymueller® SL/SLL 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™ Zweymueller™ SL/SLL Femoral Stem is designed as a conical straight stem with a rectangular cross section to ensure rotational stability. Distally the SLL stem is up to 20% longer than the same size SL stem, while maintaining the same conical features. This provides the surgeon with greater freedom of choice even in primary operations. A SLL stem of the same size as the pre-selected SL stem can be implanted to achieve primary stability in cases of unexpected poor bone quality. Distally the stem is anchored primarily by its edges; proximally the surfaces anchor against the bone cortex.
The general design of the Alloclassic™ Zweymueller™ SL/SLL Femoral Stem with the slim neck and short taper remains unchanged as compared to the design of the previously cleared Zweymueller™ SL Femoral Stem.
The modified design increases the patient's range of motion by up to 12° following a total hip replacement. The risk of impingement and ultimately the risk of dislocation are reduced following a total hip replacement.
The Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is manufactured from wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11 / ASTM F1295-92). The entire stem below the neck of the hip stem is grit blasted to provide enhanced bone/prosthesis interface.
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
030373
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™ Zweymueller™ SL/SLL Femoral Stem.
| Manufacturer: | Centerpulse Orthopedics Ltd.
Altgasse 44
CH-6340 Baar, Switzerland | MAR 0 6 2003 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------|
| US Distributor: | Centerpulse Orthopedics Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 | |
| Date: | January 31, 2003 | |
| Contact Person: | Audrey Swearingen, RAC
Manager, Regulatory Affairs
(512) 432-9255 | |
| 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: | Alloclassic™ Zweymueller™ SL/SLL Femoral Stem | |
PRODUCT DESCRIPTION
The Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is designed as a conical straight stem with a rectangular cross section to ensure rotational stability. Distally the SLL stem is up to 20% longer than the same size SL stem, while maintaining the same conical features. This provides the surgeon with greater freedom of choice even in primary operations. A SLL stem of the same size as the pre-selected SL stem can be implanted to achieve primary stability in cases of unexpected poor bone quality. Distally the stem is anchored primarily by its edges; proximally the surfaces anchor against the bone cortex.
The general design of the Alloclassic™ Zweymueller™ SL/SLL Femoral Stem with the slim neck and short taper remains unchanged as compared to the design of the previously cleared Zweymueller™ SL Femoral Stem.
The modified design increases the patient's range of motion by up to 12° following a total hip replacement. The risk of impingement and ultimately the risk of dislocation are reduced following a total hip replacement.
The Alloclassic™ Zweymueller™ SL/SLL Femoral Stem is manufactured from wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11 / ASTM F1295-92). The entire stem below the neck of the hip stem is grit blasted to provide enhanced bone/prosthesis interface.
1
030373
page dof2
SPECIFIC DIAGNOSTIC INDICATIONS
There have been no changes in the diagnostic indications for use of the previously cleared device as a result of this modification.
The Alloclassic™ Zweymueller® SL/SLL 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 Centerpulse Orthopedics acetabular components and metallic or ceramic femoral heads possessing a 12/14 taper.
The indications for use of the Alloclassic™ Zweymueller® SL/SLL 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™ Zweymueller™ SL/SLL Femoral Stem is substantially equivalent to the previously cleared, Zweymueller™ SL Femoral Stem (ref. K962101 as Exhibit 9) as it has the same indications for use, basic design, sizes, material, sterilization method of manufacture.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wing. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper portion of the circle. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 6 2003
Ms. Audrey Swearingen, RAC Manager, Regulatory Affairs Centerpulse Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717
Re: K030373
Trade/Device Name: Alloclassic" Zwevmueller" SL/SLL Femoral Stem Regulation Numbers: 21 CFR 888.3353 Regulation Names: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO. JDI. KWY. KWL Dated: January 31, 2003
Received: February 4, 2003
Dear Ms. Swearingen:
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 Page 2 - Ms. Audrey Swearingen, RAC
3
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 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 Part 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,
Sincerely yours,
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
K030373
510(k) Number (if known):
Device Name: Alloclassic™ Zweymueller TM SL/SLL Femoral Stem
Indications for Use:
The Alloclassic™ Zweymueller™ SL/SLL 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 requires 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 Millam
Division Sign-Off
(Optional Format 1-2-96)
Division of General, Restorative
and Neurological Services
510(k) Number K030373