(118 days)
Not Found
No
The document describes a mechanical hip stem prosthesis and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to replace damaged hip joint articulation to increase patient mobility and reduce pain, which are therapeutic benefits.
No
The device description clearly states it is a "Hip Stem Prosthesis," intended to replace a damaged hip joint, indicating it is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description clearly states it is a hip stem prosthesis, which is a physical implant, not software.
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 and Intended Use: The provided text clearly describes a surgical implant intended to replace a damaged hip joint. It is a physical prosthesis implanted into the body, not a device used to analyze samples outside the body.
The information provided focuses on the physical characteristics of the hip stem, its intended surgical use, and the patient conditions it is designed to address. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
N/A
Intended Use / Indications for Use
The DePuy S-ROM® Hip Stem Prosthesis is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the component.
The DePuy S-ROM® Hip Stem Prosthesis is indicated for uncemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joints of patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicted for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, KWA
Device Description
The subject DePuy S-ROM® Hip Stem is a line extension to the 36mm S-ROM® titanium stems previously cleared in K961939 and K851422. The line extension adds a +12L option to the previously cleared standard stem sizes 19 x 24 x 175 w/36mm neck and 21 x 26 x 175 w/36mm neck. These two new stems will provide greater lateralization (+12 mm) to the standard stem of comparable diameters. The increased lateralization assists in restoring anatomical biomechanics through adjusting off-set without effecting leg length.
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): 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
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
in and frances are monder
-:
SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Orthopaedics Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
EST REG No.: 1818910 |
| --------------- | -------------------------------------------------------------------------------------------------------- |
|---|
| AUG 2 8 2006 | |
|---|---|
| -- | -------------- |
| 510(K) CONTACT: | Anne Schuler
Sr. Regulatory Affairs Specialist
Tel: (574) 372-7098
Fax: (574) 371-4987 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| DATED PREPARED: | June 22, 2006 |
| TRADE NAME: | DePuy S-ROM® STD Hip Stem Prosthesis |
| COMMON NAME: | Cementless Hip Stem Prosthesis |
| CLASSIFICATION: | 21 CFR 888.3358 Hip joint metal/polymer/metal semi-
constrained porous coated uncemented prosthesis,
Class II |
| | 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-
constrained cemented or non-porous uncemented prosthesis,
Class II |
| | 21 CFR 888.3330 Hip joint metal/metal semi-constrained,
with an uncemented acetabular component prosthesis,
Class III |
| DEVICE PRODUCT CODES: | LPH, LZO, KWA |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | DePuy S-ROM® Femoral Hip Stem (K961939, cleared
August 13, 1996) |
| | DePuy S-ROM® STD Hip Stem Prostheses (K851422,
cleared July 9, 1985 with additional modifications |
DEVICE DESCRIPTION:
The subject DePuy S-ROM® Hip Stem is a line extension to the 36mm S-ROM® titanium stems previously cleared in K961939 and K851422. The line extension adds a +12L option to the previously cleared standard stem sizes 19 x 24 x 175 w/36mm neck and 21 x 26 x 175 w/36mm neck. These two new stems will provide greater lateralization (+12 mm) to the standard stem of comparable diameters. The increased lateralization assists in restoring anatomical biomechanics through adjusting off-set without effecting leg length.
cleared through internal documentation)
0000007
1
INTENDED USE AND INDICATIONS:
INTENDED USE:
The DePuy S-ROM® Hip Stem Prosthesis is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the component.
INDICATIONS FOR USE:
The DePuy S-ROM® Hip Stem Prosthesis is indicated for uncemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joints of patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicted for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.
SUBSTANTIAL EQUIVALENCE:
The fundamental scientific technologies of the subject DePuy S-ROM® Hip Prosthesis have not changed from the FDA-cleared DePuy S-ROM® Hip Stem (K961939). They have the same intended use, indications, sterilization method, packaging, materials, method of manufacture and design. DePuy believes that the subject DePuy S-ROM® Hip Prosthesis is substantially equivalent to the FDAcleared DePuy S-ROM® Hip Stem (K961939).
0000008
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services (HHS). The logo features the HHS symbol, which is a stylized representation of a human figure embracing a globe. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2006
Ms. Anne Schuler Senior Regulatory Affairs Specialist DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
K061221 Re.
Trade/Device Name: S-ROM STD Hip Stem Prosthesis Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Codes: KWA, LZO, LPH Dated: August 16, 2006 Received: August 17, 2006
Dear Ms. Schuler:
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
3
Page 2 - Ms. Anne Schuler
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Oaibaie Buellm
Mark N. Melkerson, M.S Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
15061221 510(k) Number (if known): Device Name: DePuy S-ROM® Hip Stem Prosthesis
Indications for Use:
The DePuy S-ROM® Hip Stem Prosthesis is indicated for uncemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joints of patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicted for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.
| Prescription Use | X (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use | (21 CFR 807 Subpart C) |
|---|---|---|---|---|
| ------------------ | ------------------------------- | -------- | ---------------------- | ------------------------ |
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| Kaubare BuchelD | |
|---|---|
| for MKM |
0000COG
| 510(k) Number | K061221 |
|---|---|
| --------------- | --------- |