(147 days)
Not Found
No
The device description and intended use focus solely on the mechanical components and materials of a hip stem, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a femoral component of a total hip replacement, used to treat various joint diseases, correct deformities, and address fractures, which are all therapeutic interventions aimed at restoring function and alleviating symptoms.
No
This device is a hip stem and its modular components, intended for use as a femoral component in total hip replacement, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components made of titanium alloy and cobalt chromium alloy, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The Apex Modular Hip Stem is a physical implant designed to replace the femoral component of a hip joint. It is surgically implanted into the patient's body.
- Intended Use: The intended use is for primary total hip replacement and revision procedures, addressing conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a surgical intervention, not a diagnostic test performed on a specimen.
The description clearly indicates a surgically implanted medical device, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The Apex Modular Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:
- Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis:
- . Rheumatoid arthritis:
- Correction of functional deformity; .
- Congenital dislocation: .
- Revision procedures where other treatments or devices have failed; .
- . Femoral neck and trochanteric fractures of the proximal femur.
Product codes
LPH
Device Description
The Apex Modular Hip Stem consists of three modular components, with various sizes available for each component: the porous coated femoral stem, a modular neck that connects to the proximal end of the femoral stem, and a modular head that connects to the tapered trunion on the neck. This configuration allows the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The various neck sizes allow for several length and lateral offset options for a given stem size. The modular heads are available in standard diameters so as to fit appropriate commercially available acetabular components of the surgeons' choosing. Several offset options are also available for the heads to allow further refinement of the lengths and offsets. The Apex Modular Hip Stem may be used in conjunction with the Link® SPII® Acetabular Cup for total hip arthroplasty.
The femoral stem and neck components are manufactured from titanium alloy, and the head components are manufactured from wrought cobalt chromium alloy, the same materials used to manufacture the predicate hip stems and heads, respectively. The proximal metaphyseal region of each size femoral stem is circumferentially coated with unalloyed titanium applied by plasma spray. The alignment pin in the femoral stem is manufactured from wrought cobalt chromium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral component of a primary total hip replacement
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)
Performance testing of the modular stem has been completed as per the relevant FDA guidance documents, including assembly testing of the neck-stem modular connection and fatigue testing of the assembled device. Performance testing of the plasma sprayed unalloyed (CP) titanium coating was completed as per the relevant FDA guidance documents with data in the referenced Device Master File.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K913231, K934412, K954935, K921274
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
510(K) Summary K000788
Apex Modular™ Hip Stem
May 5, 2000
- Submitter: Apex Surgical™, LLC 39 Taunton Green Suite 202 Taunton, MA 02780
Contact: Edward J. Cheal, Ph.D. Managing Director (508) 884-9611 (voice) (508) 884-9816 (fax)
2. Device Name
Proprietary Name: Apex Modular™ Hip Stem Common Name: Hip prosthesis, uncemented Classification Name: Hip joint metal/polymer/metal semi-constrained porouscoated uncemented prosthesis Regulatory Class: Class II per 21 CFR §888.3358
3. Intended Use
The Apex Modular Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:
- Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis:
- . Rheumatoid arthritis:
- Correction of functional deformity; .
- Congenital dislocation: .
- Revision procedures where other treatments or devices have failed; .
- . Femoral neck and trochanteric fractures of the proximal femur.
4. Device Description
The Apex Modular Hip Stem consists of three modular components, with various sizes available for each component: the porous coated femoral stem, a modular neck that connects to the proximal end of the femoral stem, and a modular head that connects to the tapered trunion on the neck. This configuration allows the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The various neck sizes allow for several length and lateral offset options for a given stem size. The modular heads are available in standard diameters so as to fit appropriate commercially available acetabular components of the surgeons' choosing. Several offset options are also available for the heads to allow further refinement of the lengths and offsets. The Apex Modular Hip Stem may be used in conjunction with the Link® SPII® Acetabular Cup for total hip arthroplasty.
The femoral stem and neck components are manufactured from titanium alloy, and the head components are manufactured from wrought cobalt chromium alloy, the same materials used to manufacture the predicate hip stems and heads, respectively. The proximal metaphyseal region of each size femoral stem is circumferentially coated with
1
Image /page/1/Picture/0 description: The image shows the logo for Apex Surgical. The logo consists of a stylized letter A on the left, followed by the words "Apex Surgical" in a bold, sans-serif font. The letters are all black, and there is a small trademark symbol to the right of the word "Surgical".
unalloyed titanium applied by plasma spray. The alignment pin in the femoral stem is manufactured from wrought cobalt chromium alloy.
5. Predicate Device Comparison
Substantial equivalence is claimed to the S-ROM® Femoral Stem and the Biomet Modular Hip System. The table below compares the features and characteristics of the Apex Modular Hip Stem to these predicate devices.
| | Apex Modular
Hip Stem | S-ROM®
Femoral Stem
(K913231, K934412,
and K954935) | Biomet Modular
Hip System
(K921274) |
|---------------------------------------------------------------|--------------------------|--------------------------------------------------------------|-------------------------------------------|
| INTENDED USE | | | |
| Primary and revision hip
replacement, non-
cemented use | Yes | Yes | Yes |
| DESIGN | | | |
| Plasma spray coating | Yes | No (sintered
beads) | Yes |
| Proximal coating (only) | Yes | Yes | Yes |
| Modular head | Yes | Yes | Yes |
| Modular stem | Yes - modular
neck | Yes - modular
sleeve | Yes - modular
distal stem |
| Straight distal stem | Yes | Yes | Yes |
| Fluted stem | Yes | Yes | Yes |
| Distal slot(s) | Yes - 1 or 2
slots | Yes - 1 slot | Yes - 1 slot |
| Proximal steps | Yes | Yes | No |
| MATERIALS | | | |
| Titanium alloy (Ti6Al4V)
stem and neck | Yes | Yes | Yes |
| Cobalt chromium alloy
head | Yes | Yes | Yes |
| Titanium porous coating | Yes - unalloyed | Yes - unalloyed | Yes - Ti6Al4V |
The two most significant differences between the Apex Modular hip stem and the two predicate hip stems relate to the design of the stem modularity (modular neck versus modular stem and sleeve for the S-ROM® or modular distal stem for the Biomet Modular) and the porous coating (plasma sprayed CP titanium versus sintered bead CP titanium for the S-ROM® or plasma sprayed titanium alloy for the Biomet Modular). Performance testing of the modular stem has been completed as per the relevant FDA guidance documents, including assembly testing of the neck-stem modular connection and fatigue testing of the assembled device. Performance testing of the plasma sprayed unalloyed (CP) titanium coating was completed as per the relevant FDA guidance documents with data in the referenced Device Master File.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 2000 AUG
Edward J. Cheal, Ph.D. Managing Director Apex Surgical, LLC 39 Taunton Green Suite 202 Taunton, Massachusetts 02780
Re: K000788
Trade Name: Apex Modular™ Hip Stem Regulatory Class: II Product Code: LPH Dated: May 11, 2000 Received: May 12, 2000
Dear Dr. Cheal:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your bected. B r (x) xe is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the encreater) to teal Device Amendments, or to devices that have been reclassified in chactifient unto of the Federal Food, Drug, and Cosmetic Act (Act): You may, therefore, market the device, subject to the general control provisions of the Act. The general thereolo, incribed of the Act include requirements for annual registration, listing of devices, condor provisions of the or the , labeling, and prohibitions against 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 regulations (1 remarket ripproval), in the Code of Federal Regulations, Title 21, Parts 800 to 895. arretmig Jour as a revealent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mopolitish the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: 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 regulations.
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.
3
Page 2 - Edward J. Cheal, Ph.D.
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Donna R. Lochner.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use Device Name: Apex Modular™ Hip Stem K 000788
The Apex Modular™ Hip Stem is intended for use as the femoral component of a The Apcx Moudlar - Tip Stom to infernoral hip stem is intended for uncemented fixation primary total hip replacement. This forthering in a prosthesis may be used for the following conditions, as appropriate:
- Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis;
- Rheumatoid arthritis; ●
- Correction of functional deformity; �
- Congenital dislocation; .
- Revision procedures where other treatments or devices have failed; .
- Femoral neck and trochanteric fractures of the proximal femur.
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. Vochner
510(k) Number
Prescription Use_ X (Per 21 CFR §801.109) OR
Over-the-Counter Use
(Optional Format 1-2-96)