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ENDOTEC, INC.

Last updated May 23, 2026

What ENDOTEC, INC. makes

Endotec, Inc. manufactures orthopaedic implants including cruciate-retaining total knee prostheses, ceramic-on-polyethylene total hip prostheses, bipolar humeral and femoral head components for hemiarthroplasty, total shoulder prostheses, resurfacing humeral and metallic hip prostheses, and non-bioabsorbable orthopaedic bone screws.

The company’s portfolio includes devices regulated as Class II and Class III under FDA requirements, with submissions recorded in the FDA 510(k) and UDI registries. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Endotec, Inc. manufacture?

Endotec, Inc. specializes in orthopaedic implants, including devices like cruciate-retaining total knee prostheses, ceramic-on-polyethylene total hip prostheses, bipolar humeral and femoral head components for hemiarthroplasty, total shoulder prostheses, resurfacing humeral and metallic hip prostheses, and non-bioabsorbable orthopaedic bone screws. These products are designed to replace or repair damaged joints and bone structures.

Where is Endotec, Inc. based, and how does that affect its regulatory standing?

Endotec, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under FDA’s risk-based system (Class II or Class III). This means submissions for these devices are tracked in FDA registries like the 510(k) and UDI databases, ensuring compliance with U.S. medical device authorization requirements.

Which regulatory registries list Endotec, Inc.’s devices, and why?

Endotec, Inc.’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) submission is required for Class II devices to demonstrate substantial equivalence to a predicate device, while the UDI system ensures unique identification and traceability of Class II and Class III devices throughout their lifecycle. These registries help track compliance and authorization status for each device type.

How are Endotec, Inc.’s devices classified under FDA regulations?

Endotec, Inc.’s devices are classified as either Class II or Class III under FDA regulations. Class II devices generally pose moderate risk and require special controls beyond general controls, while Class III devices are high-risk and require premarket approval (PMA) due to insufficient data to ensure safety and effectiveness through less stringent means. The classification depends on the device’s intended use and potential risk to patients.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
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PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 803488357

Catalogue (580)

Page 12 of 12

Device	Model / Reference	Registries	Class	Status
B-P Total Knee System	04-31-1206	FDA UDI	Class II	Unknown
B-P Total Hip System	01-17-3257	FDA UDI	Class II	Unknown
B-P Total Hip System	01-16-0713	FDA UDI	Class II	Unknown
B-P Total Knee System	04-31-1105	FDA UDI	Class II	Active
B-P Total Knee System	04-32-0065	FDA UDI	Class II	Unknown
B-P Total Hip System	01-16-0716	FDA UDI	Class II	Unknown
B-P Total Hip System	01-03-0032	FDA UDI	Class II	Unknown
B-P Total Hip System	01-16-0715	FDA UDI	Class II	Active
B-P Total Shoulder System	02-02-2444	FDA UDI	Class II	Unknown
B-P Total Hip System	01-16-0615	FDA UDI	Class II	Unknown
B-P Total Hip System	01-16-0518	FDA UDI	Class II	Unknown
B-P Total Hip System	01-16-0110	FDA UDI	Class II	Unknown
B-P Total Hip System	01-01-0066	FDA UDI	Class II	Active
B-P Total Hip System	01-16-0710	FDA UDI	Class II	Active
B-P Total Knee System	04-32-0821	FDA UDI	Class II	Active
Modified New Jersey Femoral Hip Resurfacing Compon	K904870	FDA 510(k)	Class II	Active
Beuchel-Pappas Glenoid Component	K904879	FDA 510(k)	Class II	Active
Fanning-Pappas Modular Knee Bearing	K081400	FDA 510(k)	Class II	Active
Buechel-Pappas Polyethylene Glenoid Component (02-11-Yyxx) Note:yy=id & Xx=od	K960424	FDA 510(k)	Class II	Active
Dekalb	K944414	FDA 510(k)	Class II	Active
Tronzo Acetabular Fixation Component (1 99-02-00xx (ace. Fixation Cup) Xx=od Of Ace. Cup	K963100	FDA 510(k)	Class II	Active
Electrosurgical Cutting & Coagulation Device Accessories	K945254	FDA 510(k)	Class II	Active
Buechel-Pappas Modular Salvage Stem	K982418	FDA 510(k)	Class III	Active
Buechel-Pappas Polyethlene Acetabular Component(01-42-Yyxx & 01-43-Yyxx	K960425	FDA 510(k)	Class II	Active
Carrier, Ligature (79 Gej)	K944465	FDA 510(k)	Class II	Active
Buechel-Pappas Extended Collar Femoral Stem Prosth	K905262	FDA 510(k)	Class II	Active
Buechel-Pappas Humeral Stem Component	K904880	FDA 510(k)	Class II	Active
Buechel-Pappas (b-P) Fixed Bearing New Jersey (nj) Total Knee, Model 1	K012702	FDA 510(k)	Class II	Active
Buechel-Pappas Humeral Head Resurfacing Component	K992394	FDA 510(k)	Class II	Active
B-P Hemispherical Acetabular Component	K963101	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

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FDA Recalls (20)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Endotec, Inc. has 20 recall records listed, all initiated between June 5, 2009, and September 21, 2011, with all records marked as terminated. The recalls involve the Beuchel-Pappas Mobile Bearing Knee System (BP Knee) due to unapproved mobile bearing components and multiple instances of the B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues, including validation failures, process variations, and inconsistent test results.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Sep 21, 2011	Z-0441-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0440-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0432-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0433-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0438-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0436-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0434-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0443-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0437-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0435-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0431-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0439-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Sep 21, 2011	Z-0442-2012	—	terminated	On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
Jun 5, 2009	Z-1622-2010	—	terminated	Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.
Jun 5, 2009	Z-1623-2010	—	terminated	Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.
Jun 5, 2009	Z-1626-2010	—	terminated	Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.
Jun 5, 2009	Z-1621-2010	—	terminated	Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.
Jun 5, 2009	Z-1625-2010	—	terminated	Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.
Jun 5, 2009	Z-1627-2010	—	terminated	Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.
Jun 5, 2009	Z-1624-2010	—	terminated	Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.