(42 days)
No
The document describes a mechanical orthopedic implant (femoral heads) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is a femoral head intended for total hip arthroplasty, which is a medical procedure to treat various joint diseases and correct deformities, thereby restoring function. These are therapeutic applications.
No
The device description and indications for use clearly describe a prosthetic implant for total hip arthroplasty, which is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical femoral head manufactured from Alumina ceramic and Ti-6Al-4V alloy, intended for surgical implantation. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a part of the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and design of a physical implant (femoral head and sleeve). IVD devices typically involve reagents, instruments, or software used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing information for diagnosis.
The device is a medical device, specifically a prosthetic implant, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use: The subject femoral heads are single-use devices intended for use in cemented or cementless total hip arthroplasty with various Howmedica Osteonics hip stems featuring the PCA® taper (2° 52') that are manufactured from CoCr alloy. They are not intended for use with any stem manufactured from Stainless Steel or Titanium alloy. They are also intended for use with any compatible, currently available Howmedica Osteonics acetabular component featuring a polyethylene bearing surface.
Indications for Use:
-
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
- rheumatoid arthritis (excepting the Osteolock" HA Acetabular Cup and Peri-2) Apatite coated prostheses):
-
- correction of functional deformity:
-
- revision procedures where other treatments or devices have failed; and,
- ૨) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The Peri-Apatite coated prostheses are indicated only for primary uncemented total hip arthroplasty for items 1, 3, & 5 above when offered for sale in the USA.
Femoral head prostheses are indicated for use in cementless total hip arthroplasty, depending upon the indications of the acetabular and femoral stem components chosen.
Product codes
LZO
Device Description
PCA® taper (2° 52') femoral heads manufactured from Alumina ceramic (ASTM F603) with a Ti-6Al-4V alloy sleeves (ASTM F136) will be available in 32mm diameters. The femoral heads will be available with 0 (standard) and +5 offsets. The PCA® taper femoral heads are compatible with a range of CoCr alloy Howmedica Osteonics PCA® taper femoral stems. The subject components are also compatible for use with a wide range of acetabular components (shells and polyethylene inserts).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K063816 pg 1 of 2
510(k) Summary of Safety and Effectiveness for the PCA® Alumina 32mm Femoral Heads
| Proprietary Name: | FEB - 2 2007
PCA® Alumina Femoral Heads |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Artificial Hip Components |
| Classification Name and Reference | Hip joint metal/ceramic/polymer semi-constrained
cemented or nonporous uncemented prosthesis:
Section 21 CFR 888.3353. |
| Regulatory Class: | Class II |
| Device Product Code(s): | LZO - prosthesis, hip, semi-constrained,
metal/ceramic/polymer, cemented or non-porous,
uncemented. |
| For Information contact: | Patricia Setti-LaPerch
Regulatory Affairs Associate
Stryker Orthopaedics
325 Corporate Drive
Mahwah, New Jersey 07430
Phone: (201) 831-5938
Fax: (201) 831-4938
E-Mail: Patricia.LaPerch@stryker.com |
| Date Summary Prepared: | January 31, 2007 |
Device Description
PCA® taper (2° 52') femoral heads manufactured from Alumina ceramic (ASTM F603) with a Ti-6Al-4V alloy sleeves (ASTM F136) will be available in 32mm diameters. The femoral heads will be available with 0 (standard) and +5 offsets. The PCA® taper femoral heads are compatible with a range of CoCr alloy Howmedica Osteonics PCA® taper femoral stems. The subject components are also compatible for use with a wide range of acetabular components (shells and polyethylene inserts).
Intended Use:
The subject femoral heads are single-use devices intended for use in cemented or cementless total hip arthroplasty with various Howmedica Osteonics hip stems featuring the PCA® taper (2° 52') that are manufactured from CoCr alloy. They are not intended for use with any stem manufactured from Stainless Steel or Titanium alloy. They are also intended for use with any
1
KU3816 pg 2 of 2
compatible, currently available Howmedica Osteonics acetabular component featuring a polyethylene bearing surface.
Indications for Use
-
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
- rheumatoid arthritis (excepting the Osteolock" HA Acetabular Cup and Peri-2) Apatite coated prostheses):
-
- correction of functional deformity:
-
- revision procedures where other treatments or devices have failed; and,
- ર) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The Peri-Apatite coated prostheses are indicated only for primary uncemented total hip arthroplasty for items 1, 3, & 5 above when offered for sale in the USA.
Femoral head prostheses are indicated for use in cementless total hip arthroplasty, depending upon the indications of the acetabular and femoral stem components chosen.
Substantial Equivalence:
The PCA® Alumina Femoral Heads are substantially equivalent to the Alumina V40™ Femoral Heads (K023901), cleared by Howmedica Osteonics Corp., PCA Total Hip System - Cementless Use (K920831), cleared by Pfizer Hospital Products Group, Inc., and the V40™/C-Taper Adapter Sleeve (K003379), cleared by Howmedica Osteonics Corp.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Orthopaedics % Ms. Patricia Setti-LaPerch Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430
FEB - 2 2007
Re: K063816 Trade/Device Name: PCA® Alumina 32 mm Femoral Heads 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: LZO Dated: December 21, 2006 Received: December 22, 2006
Dear Ms. Setti-LaPerch:
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 forth in the quality systems (QS) regulation
3
Page 2 - Ms. Patricia Setti-LaPerch
(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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Priehus
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
325 Corporate Drive Mahwah, NJ 07430 t: 201 831 5000 www.stryker.com
Image /page/4/Picture/18 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase except for the "S", which is uppercase. There is a small, superscripted circle with the letters "DC" inside it to the right of the word. The word is likely a logo or brand name.
Orthopaedics
510(k) Number (if known): K063816
Device Name: PCA® Alumina Femoral Heads
Indications for Use
- noninflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis:
- rheumatoid arthritis (excepting the Osteolock" HA Acetabular Cup and Peri-2) 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 ર) femur with head involvement that are unmanageable using other techniques.
The Peri-Apatite coated prostheses are indicated only for primary uncemented total hip arthroplasty for items 1, 3, & 5 above when offered for sale in the USA.
Femoral head prostheses are indicated for use in cementless total hip arthroplasty. depending upon the indications of the acetabular and femoral stem components chosen.
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)
fortare Puchar for MOM
(Division Sign Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K043816