K Number

Device Name

STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM

Manufacturer

BIOMET, INC.

Date Cleared

2005-12-16

(53 days)

Product Code

KWY KWL

Regulation Number

888.3390

Intended Use

Disposable cement spacer molds with stainless steel reinforcements are intended to be used to mold a hemi-hip femoral prosthesis, indicated for temporary use (maximum 180 days) in skeletally mature patients undergoing a two-stage procedure due to septic process. The temporary prosthesis is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The temporary prosthesis is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The hemi-hip femoral prosthesis is not intended for use more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection, arthroplasty, fusion, etc.) Because of inherent mechanical limitations of the material (polymethylmethacrylate/gentamicin), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

Device Description

The device consists of a sterile, assembled cement spacer mold made of medical grade silicone with a stainless steel reinforcement stem located inside the silicone mold, designed to construct a temporary cement hemihip femoral spacer. The silicone component of the spacer mold is designed to shape the temporary spacer but is not implanted, and is to be discarded after a single use. The stainless steel reinforcement stem serves as the load-bearing endoskeleton of the hemi-hip prosthetic implant and is incorporated into the prosthesis by being coated over by bone cement. Polymethylmethacrylate/gentamicin bone cement is filled into the silicone mold containing the stainless steel reinforcement stem. The temporary hip prosthesis is removed from the silicone mold after the cement hardens and is placed into the patient's hip joint space. The femoral cement spacer molds are offered in four sizes (9 mm x 125 mm/ 43mm head, 9 mm x 125 mm/ 51mm head, 13 mm x 145 mm/ 57 mm head & 17 mm x 165 mm/ 64 mm head).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K031841

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of a physical mold and temporary prosthesis, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

Yes
The document explicitly states that this device is intended to be used to mold a temporary hemi-hip femoral prosthesis for up to 180 days in patients undergoing a two-stage procedure due to septic process, which is a therapeutic intervention.

Diagnostic

The device is a disposable cement spacer mold used to create a temporary hemi-hip femoral prosthesis for patients undergoing a two-stage procedure due to a septic process. Its purpose is therapeutic (to help manage an infection and maintain the hip joint space), not diagnostic.

SaMD (Software as a Medical Device)

The device is a physical medical device consisting of silicone molds and stainless steel reinforcements used to create a temporary hip prosthesis. It does not involve any software components.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
Device Function: The device described is a surgical mold used to create a temporary bone cement prosthesis that is implanted into the patient's hip joint. It is a physical device used in vivo (within the body), not a device used to analyze samples in vitro (outside the body).
Intended Use: The intended use clearly states it's for molding a temporary femoral prosthesis for implantation during a two-stage procedure for septic processes. This is a surgical intervention, not a diagnostic test.

The document describes a medical device used in surgery, specifically an implantable prosthesis and the mold used to create it. It does not involve the analysis of biological samples for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The StageOne™ Disposable Cement Spacer Mold For Temporary Hip Prosthesis with Reinforcement Stem is intended to provide the surgeon with a means to mold a temporary hemi-hip femoral prosthesis at the point of care, using a cleared polymethylmethacrylate/gentamicin bone cement. The predicate device is a temporary hemi-hip femoral prosthesis, made with polymethylmethacrylate/gentamicin bone cement, pre-molded by the manufacturer.

The temporary prosthesis is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The temporary prosthesis is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The hemi-hip femoral prosthesis is not intended for use more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection, arthroplasty, fusion, etc.)

Because of inherent mechanical limitations of the material (polymethylmethacrylate/gentamicin), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

Product codes

KWY, KWL

Device Description

Polymethylmethacrylate/gentamicin bone cement is filled into the silicone mold containing the stainless steel reinforcement stem. The temporary hip prosthesis is removed from the silicone mold after the cement hardens and is placed into the patient's hip joint space.

The femoral cement spacer molds are offered in four sizes (9 mm x 125 mm/ 43mm head, 9 mm x 125 mm/ 51mm head, 13 mm x 145 mm/ 57 mm head & 17 mm x 165 mm/ 64 mm head).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Femoral medullary canal and acetabular cavity (hip joint space)

Indicated Patient Age Range

Skeletally mature patients

Intended User / Care Setting

Surgeon, point of care

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: Comparative mechanical (fatigue) and antibiotic (gentamicin) elution testing was performed on both the temporary hip prosthesis made with the Biomet disposable cement spacer molds and the Exactech/Tecres Spacer-G predicate device. The temporary hip prostheses were found to be substantially equivalent in fatigue characteristics. The percentage of total gentamicin eluted from the spacer made from a Biomet mold and antibiotic-loaded G bone cement was substantially equivalent to the percentage of gentamicin eluted from the Tecres Spacer-G.

Clinical Testing: No clinical testing was performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K031841

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.

Summary

Kosta990 page 143

DEC 1 6 2005

510(k) Summary

| Applicant/Sponsor: | Biomet Manufacturing Corp.
P.O. Box 587
Warsaw, Indiana 46581-0587 |

--------------------	--------------------------------------------------------------------------

Lester F. Padilla Contact Person:

Proprietary Name: StageOne™ Disposable Cement Spacer Mold For Temporary Hip Prosthesis with Reinforcement Stem

Common Name: Bone Cement Spacer Mold; Disposable Cement Spacer Molds for Temporary Hip Prosthesis

Classification Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21 CFR 888.3360); Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21 CFR 888.3390)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Spacer-G Temporary Hip Prosthesis cleared by the FDA in K031841 and marketed in the US under the InterSpace™ Hip by Exactech, Inc., Gainesville, FL.

Device Description: The device consists of a sterile, assembled cement spacer mold made of medical grade silicone with a stainless steel reinforcement stem located inside the silicone mold, designed to construct a temporary cement hemihip femoral spacer. The silicone component of the spacer mold is designed to shape the temporary spacer but is not implanted, and is to be discarded after a single use. The stainless steel reinforcement stem serves as the load-bearing endoskeleton of the hemi-hip prosthetic implant and is incorporated into the prosthesis by being coated over by bone cement.

The femoral cement spacer molds are offered in four sizes (9 mm x 125 mm/ 43mm head, 9 mm x 125 mm/ 51mm head, 13 mm x 145 mm/ 57 mm head & 17 mm x 165 mm/ 64 mm head).

Intended Use: The StageOne™ Disposable Cement Spacer Mold For Temporary Hip Prosthesis with Reinforcement Stem is intended to provide the surgeon with a means to mold a temporary hemi-hip femoral prosthesis at the point of care, using a cleared polymethylmethacrylate/gentamicin bone cement. The predicate device is a temporary hemi-hip femoral prosthesis, made with

K052990 page 293

polymethylmethacrylate/gentamicin bone cement, pre-molded by the manufacturer.

Indication for Use: Disposable cement spacer molds with stainless steel reinforcements are intended to be used to mold a hemi-hip femoral prosthesis, indicated for temporary use (maximum 180 days) in skeletally mature patients undergoing a two-stage procedure due to septic process.

Contraindications:

The temporary hip prosthesis made with the disposable cement spacer molds is contraindicated for the following situations:

The patient's condition is such that a two-stage arthroplasty procedure is ● contraindicated due to decreased immune response or other relevant systemic clinical conditions.
Lack of adequate bone structure precludes adequate support of the . prosthesis in the proximal femur or acetabular region.
The procedure is unjustified due to deficiencies in the patient's muscular, . nervous or vascular systems.
Poor bone quality (as in osteoporosis) could cause the prosthesis to . migrate or to fracture host bone.
Infection of the THR cannot be confirmed. .
The infected THR devices cannot be removed. .
A systemic or secondary remote infection is expected or confirmed. .
The patient is sensitive (allergic) to gentamicin, aminoglycosides or PMMA . bone cement.
The patient does not have a THR and the infection is secondary to . trauma, septic arthritis or other surgical procedures.
The patient does not have sufficient bone stock to allow insertion and . fixation of the prosthesis.
The patient has neuromuscular disorders that do not allow control of the . hip joint.

K052990 page 1 of 3

The patient's age, weight, or activity level would cause the surgeon to . expect early failure of the system.
The infecting pathogens are resistant to gentamicin. .
Patients with mental or neurologic conditions who are unwilling or . incapable of following postoperative care instructions.

Summary of Technologies: The bone cement molds are sterile disposables made of medical grade sillcone with a reinforcement stem. The disposable cement spacer molds produce temporary hip prosthesis components that are composed of similar bone cement and reinforcement stems as the predicate.

Non-Clinical Testing: Comparative mechanical (fatigue) and antibiotic (gentamicin) elution testing was performed on both the temporary hip prosthesis made with the Biomet disposable cement spacer molds and the Exactech/Tecres Spacer-G predicate device. The temporary hip prostheses were found to be substantially equivalent in fatigue characteristics. The percentage of total gentamicin eluted from the spacer made from a Biomet mold and antibioticloaded G bone cement was substantially equivalent to the percentage of gentamicin eluted from the Tecres Spacer-G.

Clinical Testing: No clinical testing was performed.

StageOne is a trademark of Biomet, Inc., Warsaw, IN, USA InterSpace and Spacer G are trademarks of Tecres SPA. and Exactech, Inc. Palacos G is a trademark of Heraeus Kulzer GmbH & Co.

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized caduceus symbol, which features a staff with a snake winding around it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 16 2005

Mr. Lester F. Padilla Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587

K052990 Re:

K052990
Trade/Device Name: StageOne™ Disposable Cement Spacer Mold For Temporary Hip Prosthesis with Reinforcement Stem Regulation Number: 21 CFR 888.3390 Regulation Number: 21 CFR 866.5570
Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented prosthesis Regulatory Class: Class II Product Code: KWY, KWL Dated: October 18, 2005 Received: October 24, 2005

Dear Mr. Padilla:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premainer is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and nave decemined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Device Amendments for use stated in the enclosure) to regally manced in the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chaculture with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of PMA) devices that have been recuire approval of a proval es approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require approvate controls provisions of the Act. The Act. The Act. The
You may, therefore, market the device, subject to the general You may, therefore, market the device, salger to an general registration, listing of
general controls provisions of the Act include requirements for any instruction and general controls provisions of the rict merade requires.
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 ( If your device is classified (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major and condition may be subject to such additional controller Linking Company of San Son to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 be found in the Code of Peachar Ing 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 s issuance of a succements with other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a decemmanon that your as roos by other Federal agencies. You must of any Federal statutes and regulations annuding, but not limited to: registration and issues as at comply with an the Act 3 requirements, morealing, which and acturing practice requirements as set

Page 2 – Mr. Lester F. Padilla

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in also quand by bytvisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product ratialled on 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 promated predicated 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 it you active of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark McMillan

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known):

StageOne™ Disposable Cement Spacer Mold For Temporary Hip Device Name: Prosthesis with Reinforcement Stem

Indications For Use:

Disposable cement spacer molds with stainless steel reinforcements are intended to be used to Disposable connell prosthesis, indicated for temporary use (maximum 180 days) in skeletally mature patients undergoing a two-stage procedure due to septic process.

The temporary prosthesis is inserted into the femoral medullary canal and acetabular cavity The temporary probaleste existing femoral and acetabular implants and debridement. The temporary prosthesis is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The hemi-hip femoral prosthesis is not intended for use more than 180 days, at which time it The nem-inp formanent device implanted or another appropriate treatment performed (e.g. resection, arthroplasty, fusion, etc.)

Because of inherent mechanical limitations of the material (polymethylmethacrylate/gentamicin), Decause of imeront movosthesis is only indicated for patients who will consistently use the morded temperary pro devices (e.g. crutches, walkers) throughout the implant period.

Contraindications:

The temporary hip prosthesis made with the disposable cement spacer molds is contraindicated for the following situations:

The patient's condition is such that a two-stage arthroplasty procedure is contraindicated . I he to decreased immune response or other relevant systemic clinical conditions.
Lack of adequate bone structure precludes adequate support of the prosthesis in the . proximal femur or acetabular region.
The procedure is unjustified due to deficiencies in the patient's muscular, nervous or . vascular systems.
Poor bone quality (as in osteoporosis) could cause the prosthesis to migrate or to fracture . host bone.
Infection of the THR cannot be confirmed. ●
The infected THR devices cannot be removed. .
A systemic or secondary remote infection is expected or confirmed. .
The patient is sensitive (allergic) to gentamicin, aminoglycosides or PMMA bone . cement.
The patient does not have a THR and the infects . or other surgical procedures.

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

S10(k) Number K052090

Indications for Use

Biomet Manufacturing Corp.

Biomet Manufacturing Corp.
Device Name: StageOne™ Disposable Cement Spacer Mold For Temporary Hip Prosthesis with Reinforcement Stem ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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The patient does not have sufficient bone stock to allow insertion and fixation of the . prosthesis.
The patient has neuromuscular disorders that do not allow control of the hip joint. ●
The patient's age, weight, or activity level would cause the surgeon to expect early failure ● of the system.
The infecting pathogens are resistant to gentamicin. .
The mreceing paint gor neurologic conditions who are unwilling or incapable of . following postoperative care instructions.

Prescription Use _YES (Part 21 CFR 801 Subpart D) AND/OR AND/OR

Over-The-Counter Use $\frac{N}{D}$
(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-USE ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milken

(Division Sign-Off) (Division Sign of General, Restorative, DIVIsionological Devices

Devices
K052990$_{mnr}$

510(k) Number_