(363 days)
The Hipstar® hip stem is a single-use device intended for cementless fixation within the prepared femoral canal.
The Hipstar® Hip Stem is intended for use in total and hemi hip arthroplasty for the following indications:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- rheumatoid arthritis (excepting the Osteolock" HA Acetabular Cup and Peri-. Apatite coated prosteses);
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
When mated with a constrained acctabular liner the Hipstar® Hip Stern is indicated for use in primary and revision total hip arthroplasty for patients at high risk of hip dislocation due to a history of prior dislocations, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
The Hipstar® Hip Stem is intended for cementless use only.
The Hipstar® Femoral Stem is a straight hip stem manufactured from titanium alloy, TMZFTM. The Hipstar® hip features a proximal, lateral flare for rotational stability, with a narrow distal stem for implant stability. The body of the stem, with the exception of the trunnion, neck and distal tip, is iron grit blasted for increased bone to implant interface.
The provided text is a 510(k) Summary for the HIPSTAR Femoral Stem, a medical device. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study reporting on the device's performance against specific acceptance criteria.
Therefore, the document does not contain any information regarding acceptance criteria, reported device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
The text focuses on:
- Device Description: Material, design features.
- Intended Use and Indications: When and how the device should be used.
- Substantial Equivalence: Comparison to a predicate device (Zimmer's Alloclassic™ Zweymueller™ SL/SLL femoral hip stem, K030373) based on intended use, design, and sterilization.
- Regulatory Information: Class II device, product codes, classification names.
In the context of medical device submissions like 510(k), the "acceptance criteria" and "study proving the device meets the acceptance criteria" would typically refer to bench testing, animal studies, or clinical studies demonstrating the safety and effectiveness of the device. However, this specific 510(k) summary primarily establishes substantial equivalence to a predicate device rather than presenting detailed performance study results with acceptance criteria.
Therefore, I cannot populate the requested table and information points as the provided document does not contain this type of data.
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K05/223
stryker
Howmedica
OSTEONICS
1 10
510(k) Summary of Safety and Effectiveness for the HIPSTAR Femoral Stem
325 Corporate Drive Mahwah, NJ USA 07430
Proprietary Name:
Common Name:
Regulatory Class:
Device Product Code:
Classification Name and Reference
HIPSTAR Femoral Stem
Total Hip Joint Replacement Prosthesis
Hip joint, metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prostheses, 21 CFR §888.3353
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis 21 CFR §888.3360
Hip joint metal/polymer constrained cemented or uncemented prosthesis 21 CFR §888.3310
Class II
87 LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or nonporous, uncemented
87 LWJ - prosthesis, hip, semi-constrained, metal/polymer, uncemented
87 MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium-phosphate
87 KWL - prosthesis, hip, hemi-, femoral, metal
87 KWZ - prosthesis, hip, constrained, cemented or uncemented, metal/polymer
ЭЭДАЯ
02/120
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For Information contact:
Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07432 Phone: (201) 831-5612 Fax: (201) 831-6038 E-Mail: Tiffani.Rogers@stryker.com
Date Summary Prepared:
May 5, 2006
KOS 1223
Device Description
The Hipstar® Femoral Stem is a straight hip stem manufactured from titanium alloy, TMZFTM. The Hipstar® hip features a proximal, lateral flare for rotational stability, with a narrow distal stem for implant stability. The body of the stem, with the exception of the trunnion, neck and distal tip, is iron grit blasted for increased bone to implant interface.
Intended Use:
The Hipstar® hip stem is a single-use device intended for cementless fixation within the prepared femoral canal.
Indications
The Hipstar® Hip Stem is intended for use in total and hemi hip arthroplasty for the following indications:
- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
- rheumatoid arthritis (excepting the Osteolock" HA Acetabular Cup and Peri-. Apatite coated prostheses);
- . correction of functional deformity;
- revision procedures where other treatments or devices have failed; and, ●
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal ▲ femur with head involvement that are unmanageable using other techniques.
When mated with a constrained acctabular liner the Hipstar® Hip Stern is indicated for use in primary and revision total hip arthroplasty for patients at high risk of hip dislocation due to a history of prior dislocations, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
Substantial Equivalence:
The determination of the substantial equivalence of the HIPSTAR® hip stem is based on its similarities in intended use, design and sterilization to Zimmer's Alloclassic™ Zweymueller™ SL/SLL femoral hip stem (K030373, cleared March 06, 2003).
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is a symbol of medicine and health, and it is composed of a staff with two snakes coiled around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 0 2006
Stryker® Orthopaedics % Ms. Tiffani Rogers Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07432
Re: K051223
Trade/Device Name: Hipstar® Hip Stem Regulation Number: 21 CFR 878.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Regulatory Class: II Product Code: LZO Dated: March 31, 2006 Received: April 3, 2006
Dear Ms. Rogers:
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 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
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Page 2 - Ms. Tiffani Rogers
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 (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/dsma/dsmamain.html
Sincerely yours,
Hubert Semeno
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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K051223
510(k) Number (if known): ___
Device Name: Hipstar® Hip Stem___
Indications
The Hipstar® Hip Stem is intended for use in total and hemi hip arthroplasty for the following indications:
- noninflammatory degenerative joint disease including osteoarthritis and avascular � necrosis:
- rheumatoid arthritis (excepting the Osteolock™ HA Acetabular Cup and Peri-. Apatite coated prostheses);
- correction of functional deformity; ●
- revision procedures where other treatments or devices have failed; and, ◆
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal . treatment of nonamon, remot that are unmanageable using other techniques.
When mated with a constrained acetabular liner the Hipstar® Hip Stem is indicated for use in primary and revision total hip arthroplasty for patients at high risk of hip dislocation due to a history of prior dislocations, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
The Hipstar® Hip Stem is intended for cementless use only.
X Prescription Use _____________________________________________________________________________________________________________________________________________________________
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)
Huker Lemer to
(Division Division of General. Restorative. and Neurological Devices
510(k) Number K051223
N/A