510(k) · Cleared
Recalled · Class II · 2019Compress (R) Segmental Humeral Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Orthopedics, LLC · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on May 24, 2012 as substantially equivalent to K100147 (Aesculap Implant System, Inc., 2010) and 3 other predicates after a 234-day review. Its family tree reaches back 5 generations to 1996. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- May 24, 2012
- Review
- 234 days
- Class
- Class II
- Product code
- MBF
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 5 generations to K945028 (1996). 18 ancestors in all, the oldest K913282 (1991). 5 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
- 4 generations backK031804 Compress Distal Femoral ReplacementBiomet, Inc. · 2003
- 3 generations backK041352 Compress Distal Femoral Replacement SystemBiomet, Inc. · 2004
- 2 generations backK043547 Compress Segmental Femoral Replacement SystemBiomet, Inc. · 2005 · Recalled
- 1 generation backK062998 Compress Segmental Femoral Replacement System (Short Spindle and…Biomet Manufacturing Corp · 2007 · Recalled
- This deviceK112905 Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC · 2012
- Descendant · cites it directly · 2 of its ownK173411 Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018
- Descendant · 2 generations on · 1 of its ownK223631 Comprehensive Segmental Revision System (SRS)Biomet Orthopedics · 2023
- Descendant · cites it directly · 1 of its ownK123297 Compress Segmental Humeral Replacement SystemBiomet Manufactuting Corp. · 2012
- Descendant · 3 generations on · 0 of its ownK251686 Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK183553 Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018 · cites it directly2descendants
- K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics · 2023 · 2 generations on1descendant
- K123297Compress Segmental Humeral Replacement SystemBiomet Manufactuting Corp. · 2012 · cites it directly1descendant
- K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 2025 · 3 generations on0descendants
- K183553Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945028 | Finn Knee System | Biomet, Inc. | 1996 | — |
| −4 | K031804 | Compress Distal Femoral Replacement | Biomet, Inc. | 2003 | — |
| −3 | K041352 | Compress Distal Femoral Replacement System | Biomet, Inc. | 2004 | — |
| −2 | K043547 | Compress Segmental Femoral Replacement System | Biomet, Inc. | 2005 | 6 |
| −1 | K062998 | Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug) | Biomet Manufacturing Corp | 2007 | 21 |
| 0 (this device) | K112905 | Compress (R) Segmental Humeral Replacement System | Biomet Orthopedics, LLC | 2012 | — |
| +1 | K173411 | Comprehensive Segmental Revision System (SRS) | Biomet Manufacturing Corp | 2018 | — |
| +2 | K223631 | Comprehensive Segmental Revision System (SRS) | Biomet Orthopedics | 2023 | — |
| +1 | K123297 | Compress Segmental Humeral Replacement System | Biomet Manufactuting Corp. | 2012 | — |
| +3 | K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | Tornier, Inc. | 2025 | 1 |
| +1 | K183553 | Compress and Mini Compress Anti-Rotation Spindles | Biomet, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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 MBF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBF device
- #1 K202716 Ignite Anatomic Shoulder Systemscore 20.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K100147 | S4 Cervical Occipital Plate Spinal System | 2010 |
| * | K062998 | Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)Summary page 2…Which Substantial Equivalence Is Claimed: Biomet - K1O0 1475 - Compresso Segmental Femoral Replacement System (Anti-Rotation Spindles) Biomet - K062998 - Compress® Segmental Femoral Replacement System (Short Spindle and Anchor Plug) Biomet - K033280 -… | 2007 |
| * | K033280 | Discovery Elbow-Mosaic Distal Humeral Replacement SystemSummary page 2…on Spindles) Biomet - K062998 - Compress® Segmental Femoral Replacement System (Short Spindle and Anchor Plug) Biomet - K033280 - Discovery m Elbow - Mosaic"" Distal Humeral Replacement System Biomet - K020045 - 3-Piece Proximal Humeral Replacement… | 2003 |
| * | K020045 | 3-Piece Proximal Humeral Replacement SystemSummary page 2…Replacement System (Short Spindle and Anchor Plug) Biomet - K033280 - Discovery m Elbow - Mosaic"" Distal Humeral Replacement System Biomet - K020045 - 3-Piece Proximal Humeral Replacement System (Mosaic) Device Description: The Compress® Segmental Humeral Replacement Syst… | 2002 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 21, 2019 | Class II | Z-0519-2020 | Environmental control | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. |
| Oct 12, 2018 | Class II | Z-0642-2019 | Device Design | Correction to update the surgical technique for the Compress System. To make users aware of the changes that were made only to the selection criteria section on page 42 regarding which array to use in the placement of the anti-rotation… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 7 of the 18 ancestors have a recall of any class.
- Of its descendants, K173411 (Biomet Manufacturing Corp, 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K100147.
How does its category compare?
All MBF devicesMBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MBF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBF
144in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBF
255in 2025
MAUDE reports naming product code MBF, 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 | 2 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 1 | — | 1 | 16 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 32 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 40 |
| 2014 | 1 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 49 |
| 2016 | 0 | — | 0 | 85 |
| 2017 | 2 | — | 1 | 193 |
| 2018 | 1 | — | 1 | 99 |
| 2019 | 2 | — | 2 | 47 |
| 2020 | 2 | — | 0 | 24 |
| 2021 | 1 | — | 0 | 36 |
| 2022 | 4 | 164 | 8 | 114 |
| 2023 | 4 | 144 | 1 | 143 |
| 2024 | 2 | — | 0 | 164 |
| 2025 | 2 | — | 0 | 255 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Compress® Segmental Humeral Replacement System is indicated for: 1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty. 4. Trauma. The Compress® Segmental Humeral Replacement System components are intended for uncemented use. The Discovery Elbow components when used in conjunction with the Compress® Segmental Humeral Replacement…
Read the full statement (135 words)
The Compress® Segmental Humeral Replacement System is indicated for:
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
2. Tumor resections.
3. Revision of previously failed total joint arthroplasty.
4. Trauma.
The Compress® Segmental Humeral Replacement System components are intended for uncemented use.
The Discovery Elbow components when used in conjunction with the Compress® Segmental Humeral Replacement System are restricted to the Compress® Segmental Humeral Replacement System indications and are intended to be inserted with bone cement.
The Modular Hybrid Glenoid when used in conjunction with the Compress® Segmental Humeral Replacement System is restricted to the Compress® Segmental Humeral Replacement System indications and is intended to be used with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112905: Compress (R) Segmental Humeral Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112905
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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