K Number
K053528
Device Name
SHORT CITATION FEMORAL STEM
Date Cleared
2006-01-13

(25 days)

Product Code
Regulation Number
888.3353
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The subject hip stem is a single-use, sterile device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF® 5° 40' BG trunnion. Indications: - Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. - Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. - Revision procedures where other treatments or devices have failed.
Device Description
The Short Citation® hip is an anatomic stem with a 132° neck angle. The device is manufactured from TMZF® Titanium metal and features a circumferential coating of CP titanium plasma spray and hydroxyapatite coating on the proximal body. Both the neck and the proximal stem are anteverted for proximal fill. The Short Citation® hip is available in 10 sizes with right and left orientation.
More Information

Not Found

No
The summary describes a mechanical hip stem implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.

Yes
The device is a hip stem intended for use in total hip replacement, which is a medical procedure to treat various joint diseases and injuries. This falls under the definition of a therapeutic device as it is used to treat or alleviate a medical condition.

No
The device is a hip stem intended for use in total hip replacement, which is a reconstructive and therapeutic procedure, not a diagnostic one.

No

The device description clearly states it is a physical hip stem manufactured from titanium metal with coatings, indicating it is a hardware medical device.

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 provided text describes a hip stem, which is an implantable device used in surgery to replace part of the hip joint. It is a physical component inserted into the body.
  • Intended Use: The intended use clearly states it's for "total hip replacement" and "reconstruction of the head and neck of the femoral joint." This is a surgical procedure, not a diagnostic test performed on a sample outside the body.

The information provided describes a surgical implant, not a device used for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

Intended Use:

The subject hip stem is a single-use, sterile device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF® 5° 40' BG trunnion.

Indications:

  • Cementless primary hip surgery in cases of non-inflammatory degenerative joint . disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
  • Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal . femur with head involvement that are unmanageable using other techniques.
  • Revision procedures where other treatments or devices have failed. .

Product codes (comma separated list FDA assigned to the subject device)

87 MEH, 87 LZO

Device Description

The Short Citation® hip is an anatomic stem with a 132° neck angle. The device is manufactured from TMZF® Titanium metal and features a circumferential coating of CP titanium plasma spray and hydroxyapatite coating on the proximal body. Both the neck and the proximal stem are anteverted for proximal fill. The Short Citation® hip is available in 10 sizes with right and left orientation.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

femoral joint, proximal 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)

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.

K993768

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

/Stryker
Howmedica

JAN ] 3 2006

K053528

510(k) Summary of Safety and Effectiveness for the

Short Citation® Femoral Stem

325 Corporate Drive Mahwah, NJ USA 07430

Proprietary Name:Short Citation® Femoral Stem
Common Name:Total Hip Joint Replacement Prosthesis
Classification Name and ReferenceHip joint, metal/ceramic/polymer semi-
constrained cemented or nonporous
uncemented prostheses,
21 CFR §888.3353
Regulatory Class:Class II
Device Product Code:87 MEH - prosthesis, hip, semi-constrained,
uncemented, metal/polymer, non-porous,
calcium-phosphate,
87 LZO - prosthesis, hip, semi-constrained,
metal/ceramic/polymer, cemented or non-
porous, uncemented
For Information contact:Tiffani Rogers
Regulatory Affairs Specialist
Stryker Orthopaedics
325 Corporate Drive
Mahwah, New Jersey 07430
Phone: (201) 831-5412
Fax: (201) 831-6038
E-Mail: Tiffani.Rogers@stryker.com
Date Summary Prepared:December 16, 2005

Device Description

The Short Citation® hip is an anatomic stem with a 132° neck angle. The device is manufactured from TMZF® Titanium metal and features a circumferential coating of CP titanium plasma spray and hydroxyapatite coating on the proximal body. Both the neck and the proximal stem are anteverted for proximal fill. The Short Citation® hip is available in 10 sizes with right and left orientation.

1

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Intended Use:

The subject hip stem is a single-use, sterile device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF® 5° 40' BG trunnion.

Indications:

  • Cementless primary hip surgery in cases of non-inflammatory degenerative joint . disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
  • Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal . femur with head involvement that are unmanageable using other techniques.
  • Revision procedures where other treatments or devices have failed. .

Substantial Equivalence:

The determination of the substantial equivalence of the Short Citation® hip stem is based on its similarities in intended use, design and sterilization to the Citation® TMZF® femoral stem (K993768, cleared January 21, 2000). Predicate device information is located in Appendix E.

2

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2006

Ms. Tiffani D. Rogers Specialist, Regulatory Affairs Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430

Re: K053528

Trade/Device Name: Short Citation® Hip 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 Code: MEH, LZO Dated: December 16, 2005 Received: December 19, 2005

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

3

Page 2 – Ms. 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) rms let 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" (21 CFR 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 N. Mellekerson

Mark N. Melkerson, Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

1053528

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications

  • Cementless primary hip surgery in cases of non-inflammatory degenerative joint . disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
  • Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal . femur with head involvement that are unmanageable using other techniques.
  • Revision procedures where other treatments or devices have failed. .

Prescription Use X Use

OR

Over-the-Counter

(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)

2

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

K0535 28 510(k) Number