510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Link MP Reconstruction Hip

K955296510(k) TraditionalCleared Feb 14, 199690-day reviewClass II21 CFR 888.3350Recalls 21

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

Link America, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Feb 14, 1996 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 130 devices in its family, counting itself, has a Class I recall. 129 later devices descend from it. It has been recalled 21 times.

Decided
Feb 14, 1996
Review
90 days
Class
Class II
Product code
JDI
Recalls
21
Predicates
0

129 later devices descend from it, 7 citing it directly. 1 of the 130 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2014: 7 descendants cleared2000: 3 descendants cleared2003: 5 descendants cleared2004: 3 descendants cleared1999: 1 descendant cleared2012: 5 descendants cleared2010: 3 descendants cleared2019: 13 descendants cleared2022: 5 descendants cleared2015: 5 descendants cleared2025: 10 descendants cleared2013: 5 descendants cleared2016: 8 descendants cleared2024: 8 descendants cleared2026: 9 descendants cleared2020: 9 descendants cleared2017: 8 descendants cleared2007: 2 descendants cleared, 1 with a Class I recall12008: 2 descendants cleared2006: 1 descendant cleared2023: 4 descendants cleared2021: 5 descendants cleared2011: 2 descendants cleared2018: 6 descendants cleared1995200020052010201520202025
  1. This deviceK955296 Link MP Reconstruction HipLink America, Inc. · 1996
  2. Descendant · cites it directly · 114 of its ownK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
  3. Descendant · 2 generations on · 105 of its ownK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
  4. Descendant · 3 generations on · 84 of its ownK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
  5. Descendant · 4 generations on · 73 of its ownK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
  6. Descendant · 5 generations on · 41 of its ownK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled

Showing 5 of 129 descendants. See all descendants

Descendants cleared per year

1999: 12000: 32003: 52004: 32006: 12007: 22008: 22010: 32011: 22012: 52013: 52014: 72015: 52016: 82017: 82018: 62019: 132020: 92021: 52022: 52023: 42024: 82025: 102026: 9
1999high 13 (2019) · low 0 (2001)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 129 · See all
  • K992667ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · cites it directly114descendants
  • K994286ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · 2 generations on105descendants
  • K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · 3 generations on84descendants
  • K071723Zimmer Porolock Mis StemZimmer GmbH · 2008 · 4 generations on73descendants
  • K123392Avenir Muller StemZimmer GmbH · 2013 · 5 generations on41descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955296Link MP Reconstruction HipLink America, Inc.1996—
+1K992667ZMR Hip System-Revision TaperZimmer, Inc.19991
+2K994286ZMR Hip System-Porous RevisionZimmer, Inc.200011
+3K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc.20033
+4K071723Zimmer Porolock Mis StemZimmer GmbH20082
+5K123392Avenir Muller StemZimmer GmbH20134

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200030
200350
200430
200610
200721
200820
201030
201120
201250
201350
201470
201550
201680
201780
201860
2019130
202090
202150
202250
202340
202480
2025100
202690
FIG. 1 — Lineage of K955296, 1996–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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 JDI device

  1. #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (129)

See all 129

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K992667ZMR Hip System-Revision TaperZimmer, Inc.1999114
K994126Modular-Plus Revision StemPlus Orthopedics200032
K032380Wagner Cone ProsthesisCenterpulse Orthopedics, Inc.200324
K033893Spectrum Modular SystemDePuy Orthopaedics, Inc.20048
K142187Link MP Reconstruction ProsthesisWaldemar Link GmbH & Co. KG20142
K032730Fixion Hip SystemDisc-O-Tech Medical Technologies, Ltd.20040
K992403MRP-TitanRotec Medizintechnik GmbH20000

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 16, 2013Class IIZ-2064-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2079-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2074-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2073-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2061-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2060-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2065-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2063-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2062-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2068-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2071-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2077-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2069-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2075-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2066-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2076-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2070-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2078-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2072-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2080-2013Device DesignThe trial stems were manufactured using the wrong design.
Jul 16, 2013Class IIZ-2067-2013Device DesignThe trial stems were manufactured using the wrong design.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series ( Modular Necks)…Zimmer, Inc. · 2007 · 5 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K992667 (Zimmer, Inc., 1999) has gone furthest, with 114 descendants of its own.

How does its category compare?

All JDI devices

JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDI

1in 2025

2007: 32008: 52009: 32011: 22012: 42013: 32014: 32015: 32016: 42017: 12018: 12019: 22020: 72021: 32022: 32023: 22024: 32025: 12026 (partial year): 2
2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007: 81 days median2008: 96 days median2009: 65 days median2012: 167 days median2013: 176 days median2014: 98 days median2015: 190 days median2016: 166 days median2020: 247 days median2021: 162 days median2022: 69 days median2024: 59 days median
2007high 247 (2020) · low 59 (2024)2026

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

Recalls per year · JDI

1in 2025

2007: 262008: 62009: 32010: 32011: 52012: 42013: 112014: 32015: 12016: 52017: 52018: 12019: 12020: 772025: 1
2007high 77 (2020) · low 0 (2021)2026

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

Adverse event reports per year · JDI

1,644in 2025

2007: 6962008: 8102009: 9642010: 2,0402011: 3,1602012: 5,1222013: 5,2062014: 4,9682015: 4,9062016: 3,9952017: 6,1352018: 6,7282019: 7,4072020: 4,0152021: 3,1702022: 1,9782023: 1,6352024: 1,8212025: 1,644
2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, 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
200738126696
20085966810
20093653964
20100—32,040
20112—53,160
2012416745,122
20133176115,206
201439834,968
2015319014,906
2016416653,995
20171—56,135
20181—16,728
20192—17,407
20207247774,015
2021316203,170
202236901,978
20232—01,635
202435901,821
20251—11,644
20262—0—
Cite this page

510(k) Report. “K955296: Link MP Reconstruction Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955296

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026