510(k) · Cleared
ClearedLPS Upper Extremity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · JDC Prosthesis, Elbow, Constrained, Cemented
Cleared on Dec 8, 2004 as substantially equivalent to K992065 (DePuy Orthopaedics, Inc., 1999) and 3 other predicates after a 71-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Dec 8, 2004
- Review
- 71 days
- Class
- Class II
- Product code
- JDC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K925613 (1994). 16 ancestors in all, the oldest K872084 (1987). No later device cites it as a predicate yet.
- Root · 4 generations backK925613 Proximal Humeral Replacement SystemBiomet, Inc. · 1994
- 3 generations backK020045 3-Piece Proximal Humeral Replacement SystemBiomet Orthopedics, Inc. · 2002
- 2 generations backK022079 Short and Long Soft Tissue AttachmentBiomet, Inc. · 2002
- 1 generation backK033280 Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc. · 2003 · Recalled
- This deviceK042664 LPS Upper ExtremityDepuy, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925613 | Proximal Humeral Replacement System | Biomet, Inc. | 1994 | — |
| −3 | K020045 | 3-Piece Proximal Humeral Replacement System | Biomet Orthopedics, Inc. | 2002 | — |
| −2 | K022079 | Short and Long Soft Tissue Attachment | Biomet, Inc. | 2002 | — |
| −1 | K033280 | Discovery Elbow-Mosaic Distal Humeral Replacement System | Biomet, Inc. | 2003 | 1 |
| 0 (this device) | K042664 | LPS Upper Extremity | Depuy, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric HeadSummary page 2…ty is substantiated by its similarity in indications for use, design, materials, sterilization and packaging to the Global Advantage Total Shoulder system (K992065, cleared July 12, 1999), the Biomet Orthopedic 3-piece Proximal Humeral Replacement System (K020045, cleared January 30, 2… | 1999 |
| * | K020045 | 3-Piece Proximal Humeral Replacement SystemSummary page 2…ackaging to the Global Advantage Total Shoulder system (K992065, cleared July 12, 1999), the Biomet Orthopedic 3-piece Proximal Humeral Replacement System (K020045, cleared January 30, 2002), the Biomet Orthopaedic Discovery Elbow - Mosaic Distal Humeral Replacement System (K033280,… | 2002 |
| * | K033280 | Discovery Elbow-Mosaic Distal Humeral Replacement SystemSummary page 2…Proximal Humeral Replacement System (K020045, cleared January 30, 2002), the Biomet Orthopaedic Discovery Elbow - Mosaic Distal Humeral Replacement System (K033280, cleared December 19, 2003) and the Acclaim Elbow, cleared as the DePuy Total Elbow (K992656, cleared November 05,… | 2003 |
| * | K992656 | Depuy Total Elbow SystemSummary page 2…ic Discovery Elbow - Mosaic Distal Humeral Replacement System (K033280, cleared December 19, 2003) and the Acclaim Elbow, cleared as the DePuy Total Elbow (K992656, cleared November 05, 1999). 6 DEPARTMENT OF HEALTH & HUMAN… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 16 ancestors have a recall of any class.
- 13 other devices also cite its predicate K992065.
How does its category compare?
All JDC devicesJDC Prosthesis, Elbow, Constrained, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDC
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JDC
Too few JDC 510(k)s in any year since 2007 to give a median.
Recalls per year · JDC
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDC
212in 2025
MAUDE reports naming product code JDC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 33 |
| 2008 | 0 | — | 2 | 47 |
| 2009 | 1 | — | 6 | 45 |
| 2010 | 0 | — | 0 | 86 |
| 2011 | 0 | — | 2 | 62 |
| 2012 | 0 | — | 2 | 79 |
| 2013 | 1 | — | 0 | 74 |
| 2014 | 0 | — | 0 | 79 |
| 2015 | 1 | — | 0 | 239 |
| 2016 | 1 | — | 0 | 176 |
| 2017 | 0 | — | 0 | 401 |
| 2018 | 0 | — | 0 | 248 |
| 2019 | 2 | — | 2 | 190 |
| 2020 | 0 | — | 0 | 179 |
| 2021 | 0 | — | 0 | 157 |
| 2022 | 0 | — | 0 | 129 |
| 2023 | 0 | — | 0 | 189 |
| 2024 | 0 | — | 0 | 175 |
| 2025 | 0 | — | 0 | 212 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The LPS Upper Extremity is intended for use in replacement of the proximal, mid-shaft or intercalary portion, distal and/or total humerus. This system is especially designed for cases that require extensive resection and restoration. Specific diagnostic indications for use include: * Primary bone neoplasnms (e.g., osteosarcomas, chondrosarcomas, Ewing's sarcomas) requiring extensive resection(s) and replacement(s) of the proximal and/or distal humerus; *…
Read the full statement (207 words)
The LPS Upper Extremity is intended for use in replacement of the proximal, mid-shaft or intercalary portion, distal and/or total humerus. This system is especially designed for cases that require extensive resection and restoration. Specific diagnostic indications for use include:
* Primary bone neoplasnms (e.g., osteosarcomas, chondrosarcomas, Ewing's sarcomas) requiring extensive resection(s) and replacement(s) of the proximal and/or distal humerus;
* Metastatic bone disease and pathologic fractures with extensive bone loss or where other forms of treatment such as internal fixation are inadequate;
* Patient conditions of noninflammatory degenerativejoint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal humerus;
* Patients suffering from congential or acquired deformity, such as post-traumatic deformity and/or arthritis;
* Communited fractures of the proximal, distal and/or humeral shaft where forms of fixation are indadequate;
* Persistent humeral fracture non-union;
* Patients suffering from severe cuff tear arthropathy that does not respond to any conservative therapy or better alternative surgical treatment;
* Revision shoulder or elbow arthroplasty cases requiring extensive resection(s) and replacements of the proximal, distal or total humerus.
* Severe trauma requiring extensive resection and replacement
The LPS Upper Extremity components are for CEMENTED USE ONLY.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042664 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042664: LPS Upper Extremity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042664
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026