510(k) · Cleared
ClearedCompress Segmental Humeral Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufactuting Corp. · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Nov 20, 2012 as substantially equivalent to K112905 (Biomet Orthopedics, LLC, 2012) after a 29-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Nov 20, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- MBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945028 (1996). 19 ancestors in all, the oldest K913282 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
- 5 generations backK031804 Compress Distal Femoral ReplacementBiomet, Inc. · 2003
- 4 generations backK041352 Compress Distal Femoral Replacement SystemBiomet, Inc. · 2004
- 3 generations backK043547 Compress Segmental Femoral Replacement SystemBiomet, Inc. · 2005 · Recalled
- 2 generations backK062998 Compress Segmental Femoral Replacement System (Short Spindle and…Biomet Manufacturing Corp · 2007 · Recalled
- 1 generation backK112905 Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC · 2012 · Recalled
- This deviceK123297 Compress Segmental Humeral Replacement SystemBiomet Manufactuting Corp. · 2012
- Descendant · cites it directly · 0 of its ownK183553 Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −6 | K945028 | Finn Knee System | Biomet, Inc. | 1996 | — |
| −5 | K031804 | Compress Distal Femoral Replacement | Biomet, Inc. | 2003 | — |
| −4 | K041352 | Compress Distal Femoral Replacement System | Biomet, Inc. | 2004 | — |
| −3 | K043547 | Compress Segmental Femoral Replacement System | Biomet, Inc. | 2005 | 6 |
| −2 | K062998 | Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug) | Biomet Manufacturing Corp | 2007 | 21 |
| −1 | K112905 | Compress (R) Segmental Humeral Replacement System | Biomet Orthopedics, LLC | 2012 | 2 |
| 0 (this device) | K123297 | Compress Segmental Humeral Replacement System | Biomet Manufactuting Corp. | 2012 | — |
| +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 |
|---|---|---|
| 2019 | 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? (1)
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 |
|---|---|---|---|
| * | K112905 | Compress (R) Segmental Humeral Replacement SystemSummary page 1…MEF Legally marketed device(s) Compress® Segmental Humeral Replacement System to whicth equivalence is K112905 claimed Reason for 510(k) Add compatibility to the Comprehensive@ Segmental Revision subm… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183553 | Compress and Mini Compress Anti-Rotation Spindles | 2019 | 0 |
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 16 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 8 of the 19 ancestors have a recall of any class.
- Of its descendants, K183553 (Biomet, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K112905.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123297 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123297: Compress Segmental Humeral Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123297
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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