(127 days)
No
The summary describes a mechanical implant (femoral stem) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a femoral stem used in total hip replacement, which is a medical procedure to treat various hip conditions, including degenerative joint disease and fractures, thereby restoring function and alleviating symptoms.
No
Explanation: The Taper 2™ Porous Femoral Stem is an implantable device used for total hip replacement, which is a treatment for various hip conditions, not a device used to diagnose them.
No
The device description clearly indicates it is a "Porous Femoral Stem," which is a physical implant used in hip replacement surgery. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total hip replacement. This is a device used in vivo (within the body) to replace a damaged joint.
- Device Description: The description refers to a "femoral stem," which is a component of a hip implant.
- Anatomical Site: The anatomical site is the "Femoral Hip," confirming its use within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition.
IVD devices are used to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic device used to treat a condition by replacing a joint.
N/A
Intended Use / Indications for Use
The Taper 2™ Porous Femoral Stem is indicated for use in patients requiring total hip replacement due to the following:
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
• Revision of previously failed femoral head resurfacing component
Taper 2™ Porous Femoral Stems are intended for uncemented use only.
Specific indications for compatible components that can be used with the above femoral stems include:
Constrained Liners (K030047)
Constrained liners are intended for general use in skeletally mature individuals undergoing primary and/or revision surgery at high risk of hip dislocation due to dislocation, joint or bone loss, soft [tissue] laxity, neuromuscular disease, or intra-operative instability, or whom all other options to correct instability have been considered.
OSS / Salvage Systems / Total Femur (K974558, K002757, K021380, K033871)
Salvage/Oncology Hip and Total Femur components are also indicated for cases of ligament deficiency, and revision of unsuccessful osteotomy or arthrodesis.
Interlocking Stems (K990830, K042774)
Interlocking hip stems are indicated for non-cemented application in cases of revision, fracture, or tumor where compromise of the bone or soft tissue may compromise the fixation and stability of the replacement prosthesis.
Product codes (comma separated list FDA assigned to the subject device)
LPH, MBL, KWZ, JDL, KWA, JDI, LZO, MEH, KWB, LZY, KWY
Device Description
The Taper 2™ Porous Femoral Stem is a short, tapered stem, designed to provide Device Description: The Tapel 2 - Porous Femoral Seem of Children Station of Services of Services of Services
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral
Indicated Patient Age Range
skeletally mature individuals
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)
Non-Clinical Testing: Reference literature and performance data demonstrate that the Taper 2™ Porous Non-Clinical Testing. " Reference working the predicate femoral hip stems.
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.
K030047, K974558, K002757, K021380, K033871, K990830, K042774
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
JUN 2 9 2005
510(k) Summary
| Applicant/Sponsor: | Biomet Manufacturing Corp.
56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581-0587 |
| -------------------- | ------------------------------------------------------------------------------------------------ |
|---|
Kacy Arnold, RN, MBA Contact Person: Requlatory Specialist
Taper 2™ Porous Femoral Stem Proprietary Name:
Femoral Hip Stem Common Name:
Classification Name: The Taper 2™ Porous Femoral Stems included in this submission have the following classification:
-
- Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis (21 CFR §888.3358), Product Code: LPH
- (21 Cl R good:3550); Frouder South and Course Coated uncemented prosthesis (21 CFR §888.3358), Product Code: MBL
The mating components (modular heads and acetabular shells/liners) for use with the Taper 2™ Porous Femoral Stems have the following classifications:
-
- Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR §888.3310), Product Code: KWZ
- (21 CFR §888.3320), Product Code: JDL
- (21 CTK 9000.5520), Fryades SS3207, 119888888888.
- Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis (21 CFR §888.3330), Product Code: KWA
-
- Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR§ 888.3350), Product Code: JDI
- (21 Cl Rg 000.5550); Trought semi-constrained cemented or nonporous uncemented prosthesis (21 CFR §888.3353), Product Code: LZO
-
- Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR §888.3353), Product Code, MEH
- C.F.R. §888.3358), Product Code: LPH
- C.T. .N. good.JJJ0), Louder sease ar ...
Hip joint metal/polymer/metal semi-constrained, porous-coated, uncemented prosthesis (21 C.F.R. §888.3358), Product Code: MBL -
- Hip joint (hemi-hip) acetabular metal cemented prosthesis, (21 CFR §888.3370), Product Code: KWB
1
K05C441 (pg 2 of 2)
-
- Hip joint (hemi-hip) acetabular metal cemented prosthesis (21 CFR §888.3370), Product Code: LZY
- (21 CFR good.5570), frought beauty of the states or uncemented or uncemented prosthesis
- (21 CFR§888.3390), Product Code: KWY
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
TaperLoc® Porous and Reduced Distal Femoral Stems – Biomet (K921301) TaperLoc' Torous and 'Alp Prosthesis - Zimmer Inc. (K943230)
Device Description: The Taper 2™ Porous Femoral Stem is a short, tapered stem, designed to provide Device Description: The Tapel 2 - Porous Femoral Seem of Children Station of Services of Services of Services
Indications for Use: Taper 2™ Porous Femoral Stems
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 1.
- Rheumatoid arthritis 2.
- Correction of functional deformity 3.
- Correction of functional deformisy
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal 4. freathern of non-unfony ront, unmanageable using other techniques. - Revision of previously failed femoral head resurfacing component. 51
The Taper 2™ Porous Femoral Stems are intended for non-cemented use only.
Summary of Technologies: The Taper 2™ Porous Femoral Stems are maderials and Summary of Technologies. The Tapel 2 - 1 orous Centralia Center of Children devices. Testing utlize the same manufacturing, packaging and the predicate stems.
Non-Clinical Testing: Reference literature and performance data demonstrate that the Taper 2™ Porous Non-Clinical Testing. " Reference working the predicate femoral hip stems.
All trademarks are property of Biomet, Inc.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
JUN 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tracy Bickel Johnson, RAC Manager of Regulatory Affairs Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K050441
Trade/Device Name: Taper 2TM Porous Femoral Stem Trade/Device Namber: 21 CFR 888.3358, 888.3320, 888.3320, 888.3330, 888.3350, 888.3353.888.3370, 888.3390 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated, ring Joint mottarpoorstis; Hip joint metal/polymer constrained cemented ancemented prosthesis; Hip joint metal/metal semi constrained, with a cemented acetabular component, prosthesis; Hip joint metal/metal semiconstrained, with an uncemented acetabular component; Hip joint metal/ polymer semi-constrained cemented prosthesis; Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis; Hip joint (hemi-hip) acetabular metal cemented prosthesis; Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. Regulatory Class: III Regulatory Class: 111
Product Code: LPH, MBL, KWZ, JDL, KWA, JDI, LZO, MEH, KWB, LZY, KWY
Dated: May 26, 2005 Received: May 27, 2005
Dear Ms. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosary to regists of the Medical Device Amendments, or to connine.co. proc to May 20, 1978, are eccordance with the provisions of the Federal Food, Drug. de rices that have been recuire in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mains of the Act include requirements for annual registration, listing of general controls providing practice, labeling, and prohibitions against misbranding and adulteration.
3
Page 2 - Ms. Tracy Bickel Johnson, RAC
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA may be subject to such additional controller Extrong components of the 200 to 898. In addition, FDA may be found in the Code of Poderal Regaring your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issuation of a bulsvice complies with other requirements of the Act that FDA has made a decommation administered by other Federal agencies. You must of any Federal statutes and regulations and admitted to: registration and listing (21 comply with an the Act 3 requirements, news 801); good manufacturing practice requirements as set and CFK Fart 807), adoling (21 CFR Part 820), and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product Tadiation control provisions (Detice on the vice as described in your Section 510(k) I mis letter will anow you to begin manenes , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , premarket notification. THC 12/1 miding of bassification 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 If you desire specific advice ion your as (240) 276-0210. Also, please note the regulation entitled, Colliact the Office of Compunance in (21CFR Part 807.97). You may obtain Misolanding by release to premainters in the Act from the Division of Small other general information on your response 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,
Stupt Rlurcher
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices . Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Taper 2™ Porous Femoral Stem
Indications For Use:
The Taper 2™ Porous Femoral Stem is indicated for use in patients requiring total hip replacement due to the following:
- ving:
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis
- · Correction of functional deformity
- · Correction of functional delomity
· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur Treatment or non anion, remoration, remorageable by other techniques - . with head involvement, unmanageable a) one in the may component
Taper 2™ Porous Femoral Stems are intended for uncemented use only.
Specific indications for compatible components that can be used with the above femoral stems include:
Constrained Liners (K030047)
. ←
Constrained liners are intended for general use in skeletally mature individuals undergoing primary and/or Constrained liners are intended for general use in skilocation, point or bone loss, soft
revision surgery at high risk of hip dislocation due to hislocation, joint or popilon revision surgery at high histocation duct of instoly of prefer and reason of or whom all other options to
[tissue] laxity, neuromuscular disease, or intra-operative instabili [tissue] laxity, nedromasomaline and been considered.
OSS / Salvage Systems / Total Femur (K974558, K002757, K021380, K033871)
Salvage/Oncology Hip and Total Femur components are also indicated for cases of ligament deficiency, and Salvage/Oncology Hip and Total Femal components and the Components.
The forma and revision of unsuccessful osteotomy or arthrodesis.
Interlocking Stems (K990830, K042774)
Interlocking hip stems are indicated for non-cemented application in cases of revision, tracture, Interlocking hip stems are indicated for norrecented application in above for any compromise the fixation and stability oneology of the replacement prosthesis.
Prescription Use ___X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) li
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Division of General, Restorative, | |
| and Neurological Devices |
510(k) Number_________________________________________________________________________________________________________________________________________________________________