(84 days)
Sulzer Orthopedics Natural-Hip CoCr Stem, Howmedica Precision Strata Offset Stem, Johnson & Johnson PFC Offset Stem, DePuy Endurance Offset Stem, DePuy Stability Offset Stem, Osteonics Omnifit Enhanced Offset Stem 1
Not Found
No
The description focuses solely on the physical design and materials of a hip stem implant, with no mention of software, algorithms, or data processing.
Yes
The device is a hip stem used in total hip replacement surgery to treat conditions like degenerative or inflammatory joint disease, failed previous surgeries, and revisions of failed hip arthroplasties. Its purpose is to restore joint function and alleviate pain, which aligns with the definition of a therapeutic device.
No
Explanation: The device is an orthopedic implant (hip stem) for hip replacement surgery, not a diagnostic tool. Its purpose is to treat conditions, not diagnose them.
No
The device description clearly details a physical implant made of CoCr alloy, including its design features, manufacturing process, and components for surgical implantation. This 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 clearly describes a device used in vivo (within the body) for surgical implantation in hip replacement procedures. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose or monitor conditions.
- Device Description: The description details a physical implantable device (a hip stem) made of metal, designed for surgical insertion into the femur. This is consistent with a surgical implant, not an IVD.
- Anatomical Site: The anatomical site is the "Hip joint," which is an internal part of the body where a surgical implant would be placed.
- No mention of in vitro testing: There is no mention of analyzing biological samples or performing tests outside the body.
Therefore, the Natural-Hip CoCr Offset Stern is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Natural-Hip CoCr Offset Stem is intended for cemented use only in cases of hemi- or total hip replacement for treatment of the following:
-
- Patient conditions of non-inflammatory 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 previously failed hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
LZO
Device Description
The Natural-Hip CoCr Offset Stem is a collared straight stem manufactured from forged CoCr alloy (ASTM F799). The design provides 6-7mm of offset to allow the surgeon to more closely approximate the normal femoral head center in cases where varus deformity may be present. The proximal one-third of the stem's surface is grit blasted and features normalization steps which enhance cement compression and bonding for optimal fixation of the hip stem in the femoral canal. The distal portion of the stem has a hole to allow the use of a distal centralizer for correct distal alignment. The stem also employs proximal PMMA centralizers which, along with the distal centralizer, provide for an even cement mantle. The stem employs a Sulzer 12/14 configured neck trunnion for attachment to either a metallic, Biolox, or Zirconia femoral head having a Sulzer 12/14 configured bore
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip (femoral canal)
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.
Sulzer Orthopedics Natural-Hip CoCr Stem, Howmedica Precision Strata Offset Stem, Johnson & Johnson PFC Offset Stem, DePuy Endurance Offset Stem, DePuy Stability Offset Stem, Osteonics Omnifit Enhanced Offset Stem 1
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
K9 7 368)
510(k) SUMMARY
DEC 1 9 1997
In accordance with the Food and Drug Administration Interim 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 510(k) summary for the Sulzer Orthopedics Inc. Natural-Hip CoCr Offset Stem.
| Submitter: | Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, TX 78717
(512)432-9900 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs |
| Classification Name: | 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-
constrained cemented or nonporous uncemented prosthesis |
| Common/Usual Name: | Femoral stem component for hip replacement |
| Trade/Proprietary Name: | Natural-Hip CoCr Offset Stem |
PRODUCT DESCRIPTION:
The Natural-Hip CoCr Offset Stem is a collared straight stem manufactured from forged CoCr alloy (ASTM F799). The design provides 6-7mm of offset to allow the surgeon to more closely approximate the normal femoral head center in cases where varus deformity may be present. The proximal one-third of the stem's surface is grit blasted and features normalization steps which enhance cement compression and bonding for optimal fixation of the hip stem in the femoral canal. The distal portion of the stem has a hole to allow the use of a distal centralizer for correct distal alignment. The stem also employs proximal PMMA centralizers which, along with the distal centralizer, provide for an even cement mantle. The stem employs a Sulzer 12/14 configured neck trunnion for attachment to either a metallic, Biolox, or Zirconia femoral head having a Sulzer 12/14 configured bore
SPECIFIC DIAGNOSTIC INDICATIONS:
The Natural-Hip CoCr Offset Stem is intended for cemented use only in cases of hemi- or total hip replacement for treatment of the following:
-
- Patient conditions of non-inflammatory degenerative joint disease (NEDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (IID), e.g., rheumatoid arthritis.
-
- Those patients with failed previous surgery where pain, deformity or dysfunction persists.
-
- Revision of previously failed hip arthroplasty.
1
SUBSTANTIAL EQUIVALENCE:
Substantial equivalence determination is based on comparison of the Natural-Hip CoCr Offset Stem to the following legally marketed predicate competitive devices:
- Sulzer Orthopedics Natural-Hip CoCr Stem ■
- Howmedica Precision Strata Offset Stem 해
- Johnson & Johnson PFC Offset Stem 트
- DePuy Endurance Offset Stem
- 트 트 DePuy Stability Offset Stem
- Osteonics Omnifit Enhanced Offset Stem 1
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC Ut 9 1997
Mitchell A. Dhority, RAC ·Senior Regulatory Affairs Specialist Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717
K973681 Re: Sulzer Orthopedics Natural-Hip Trade Name: CoCr Offset Stem Requlatory Class: II Product Code: LZO September 25, 1997 Dated: Received: September 26, 1997
Dear Mr. Dhority:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
3
Page 2 - Mitchell A. Dhority, RAC
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
t
510(k) Number (if known):
Device Name: Sulzer Orthopedics Natural-Hip CoCr Offset Stem _________________________________________________________________________________________________________________
49
Indications for Use:
The Natural-Hip CoCr Offset Stern is intended for cemented use only in cases of hemi- or total hip replacement for treatment of the following:
-
- Patient conditions of non-inflammatory 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 previously failed hip arthroplasty.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K973681 |
| Prescription Use | X |
| OR | |
| Over-the Counter Use |
(Optional Format 1-2-96)