510(k) Report

510(k) · Cleared

Cleared

Compress and Mini Compress Anti-Rotation Spindles

K183553510(k) TraditionalCleared Jan 22, 201933-day reviewClass II21 CFR 888.3670

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet, Inc. · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Jan 22, 2019 as substantially equivalent to K101475 (Biomet Manufacturing Corp, 2010) and 2 other predicates after a 33-day review. Its family tree reaches back 7 generations to 1996.

Decided
Jan 22, 2019
Review
33 days
Class
Class II
Product code
MBF
Recalls
None
Predicates
3

Its longest line of descent runs back 7 generations to K945028 (1996). 21 ancestors in all, the oldest K913282 (1991). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 2 other ancestors2003: 1 other ancestor2002: 2 other ancestors2007: 1 other ancestor2001: 2 other ancestors2000: 2 other ancestors1998: 1 other ancestor1996: 1 other ancestor1994: 1 other ancestor1991: 1 other ancestorK945028 · Finn Knee System · Biomet, Inc. · 1996K031804 · Compress Distal Femoral Replacement · Biomet, Inc. · 2003K041352 · Compress Distal Femoral Replacement System · Biomet, Inc. · 2004K043547 · Compress Segmental Femoral Replacement System · Biomet, Inc. · 2005 · recalledK062998 · Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug) · Biomet Manufacturing Corp · 2007 · recalledK112905 · Compress (R) Segmental Humeral Replacement System · Biomet Orthopedics, LLC · 2012 · recalledK123297 · Compress Segmental Humeral Replacement System · Biomet Manufactuting Corp. · 20121990199520002005201020152020
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 8 other ancestors4 generations back: 2 other ancestors K123297 · Compress Segmental Humeral Replacement System · Biomet Manufactuting Corp. · 2012K112905 · Compress (R) Segmental Humeral Replacement System · Biomet Orthopedics, LLC · 2012 · recalledK062998 · Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug) · Biomet Manufacturing Corp · 2007 · recalledK043547 · Compress Segmental Femoral Replacement System · Biomet, Inc. · 2005 · recalledK041352 · Compress Distal Femoral Replacement System · Biomet, Inc. · 2004K031804 · Compress Distal Femoral Replacement · Biomet, Inc. · 2003K945028 · Finn Knee System · Biomet, Inc. · 1996−50
  1. Root · 7 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
  2. 6 generations backK031804 Compress Distal Femoral ReplacementBiomet, Inc. · 2003
  3. 5 generations backK041352 Compress Distal Femoral Replacement SystemBiomet, Inc. · 2004
  4. 4 generations backK043547 Compress Segmental Femoral Replacement SystemBiomet, Inc. · 2005 · Recalled
  5. 3 generations backK062998 Compress Segmental Femoral Replacement System (Short Spindle and…Biomet Manufacturing Corp · 2007 · Recalled
  6. 2 generations backK112905 Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC · 2012 · Recalled
  7. 1 generation backK123297 Compress Segmental Humeral Replacement SystemBiomet Manufactuting Corp. · 2012
  8. This deviceK183553 Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc. · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K945028Finn Knee SystemBiomet, Inc.1996—
−6K031804Compress Distal Femoral ReplacementBiomet, Inc.2003—
−5K041352Compress Distal Femoral Replacement SystemBiomet, Inc.2004—
−4K043547Compress Segmental Femoral Replacement SystemBiomet, Inc.20056
−3K062998Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)Biomet Manufacturing Corp200721
−2K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC20122
−1K123297Compress Segmental Humeral Replacement SystemBiomet Manufactuting Corp.2012—
0 (this device)K183553Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199410
199610
199810
200020
200120
200220
200310
200710
201020
FIG. 1 — Lineage of K183553, 1996–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K202716 Ignite Anatomic Shoulder Systemscore 20.3 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K101475Compress Anti-Rotation Spindles
Summary page 6
…phosphate (21 CFR 888.3353) Predicate Device(s): Primary Predicate Device: K101475 Compress Anti-Rotation Spindles (Biomet, Inc.) Additio…
Biomet Manufacturing Corp2010—
*K112905Compress (R) Segmental Humeral Replacement System
Summary page 6
…s Anti-Rotation Spindles (Biomet, Inc.) Additional Predicates: K112905 Compress Segmental Humeral Replacement System (Biomet, Inc.)…
Biomet Orthopedics, LLC20122
*K123297Compress Segmental Humeral Replacement System
Summary page 6
…K112905 Compress Segmental Humeral Replacement System (Biomet, Inc.) K123297 Compress Segmental Humeral Replacement System (Biomet, Inc.) Description:…
Biomet Manufactuting Corp.2012—

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 23 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
  • 8 of the 21 ancestors have a recall of any class.

How does its category compare?

All MBF devices

MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · MBF

2in 2025

2007: 22008: 12009: 12012: 22013: 12014: 12017: 22018: 12019: 22020: 22021: 12022: 42023: 42024: 22025: 22026 (partial year): 1
2007high 4 (2022) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBF

144in 2023

2022: 164 days median2023: 144 days median
2007high 164 (2022) · low 144 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MBF

1in 2023

2009: 12017: 12018: 12019: 22022: 82023: 1
2007high 8 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MBF

255in 2025

2007: 22008: 72009: 162010: 242011: 322012: 302013: 402014: 282015: 492016: 852017: 1932018: 992019: 472020: 242021: 362022: 1142023: 1432024: 1642025: 255
2007high 255 (2025) · low 2 (2007)2025

MAUDE reports naming product code MBF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—02
20081—07
20091—116
20100—024
20110—032
20122—030
20131—040
20141—028
20150—049
20160—085
20172—1193
20181—199
20192—247
20202—024
20211—036
202241648114
202341441143
20242—0164
20252—0255
20261—0—

What is it indicated for?

1. Correction of 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 Femoral Replacement System components are intended for uncemented use. 1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty.…

Read the full statement (279 words)

1. Correction of 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 Femoral Replacement System components are intended for uncemented use.

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 and Nexel® 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.

When components of the Compress Segmental Humeral Replacement System are used with Biomet’s Discovery® Elbow System, the user should refer to the package insert contained with the Discovery® components for additional information (01-50-0901). Compatibility is limited to Biomet manufactured Discovery® Elbow components.

When components of the Compress Segmental Humeral Replacement System are used with the Zimmer Nexel® Elbow System, the user should refer to the package insert contained with the Nexel® components for additional information (87-6204-077-88).

When components of the Compress Segmental Humeral Replacement System are used with Biomet’s Comprehensive® Segmental Revision System, the user should refer to the package insert contained with the Comprehensive Segmental Revision System components for additional information (01-50-0911).

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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

Recent decisions in MBF

The MBF category page

  • K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive…Zimmer, Inc. · 2026
  • K251098Identity Revision Humeral StemsZimmer, Inc. · 2025
  • K250848Identity Shoulder SystemZimmer, Inc. · 2025
  • K240876Identity Shoulder SystemZimmer, Inc. · 2024
  • K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A. · 2024

https://510kreport.com/device/K183553 · printed Nov 4, 2026

Cite this page

510(k) Report. “K183553: Compress and Mini Compress Anti-Rotation Spindles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183553

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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